Today, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity (body mass index of 30 kilograms per square meter (kg/ m2) or greater) or overweight (body mass index of 27 kg/m2 or greater) with at least one weight-related condition (such as high blood pressure, type 2 diabetes or high cholesterol) for use, in addition to a reduced calorie diet and increased physical activity. Tirzepatide, the active ingredient in Zepbound, is already approved under the trade name Mounjaro to be used along with diet and exercise to help improve blood sugar (glucose) in adults with type 2 diabetes mellitus.

“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”

Approximately 70% of American adults have obesity or overweight, and many of those overweight have a weight-related condition. Losing 5% to 10% of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease in adults with obesity or overweight.

Zepbound activates receptors of hormones secreted from the intestine (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) to reduce appetite and food intake. Zepbound is administered by injection under the skin once weekly, and the dosage must be increased over four to 20 weeks to achieve the target dosages of 5 milligram (mg), 10 mg or 15 mg once weekly. The maximum dosage of Zepbound is 15 mg once weekly.

Zepbound’s effectiveness for chronic weight management (weight reduction and maintenance) in combination with a reduced-calorie diet and increased physical activity was established in two randomized, double-blind, placebo-controlled trials of adults with obesity or overweight with at least one weight-related condition. These studies measured weight reduction after 72 weeks in a total of 2,519 patients who received either 5 mg, 10 mg or 15 mg of Zepbound once weekly and a total of 958 patients who received once-weekly placebo injections. In both trials, after 72 weeks of treatment, patients who received Zepbound at all three dose levels experienced a statistically significant reduction in body weight compared to those who received placebo, and greater proportions of patients who received Zepbound achieved at least 5% weight reduction compared to placebo.
 
The larger of the two trials enrolled adults without diabetes. At the start of the trial, the average body weight was 231 pounds (105 kg) and average body mass index was 38 kg/m2. In this trial, those randomized to receive the highest approved dosage of Zepbound (15 mg once weekly) lost on average 18% of their body weight compared to those randomized to placebo.

At the start of the trial in adults with type 2 diabetes, the average body weight was 222 pounds (101 kg) and average body mass index was 36 kg/m2. Those randomized to receive the highest approved dosage of Zepbound (15 mg once weekly) lost on average 12% of their body weight compared to those randomized to placebo.

Zepbound can cause side effects such as nausea, diarrhea, vomiting, constipation, abdominal (stomach) discomfort and pain, injection site reactions, fatigue, hypersensitivity (allergic) reactions (typically fever and rash), burping, hair loss and gastroesophageal reflux disease.

Zepbound causes thyroid C-cell tumors in rats. It is unknown whether Zepbound causes such tumors, including medullary thyroid cancer, in humans. Zepbound should not be used in patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2.

Zepbound has not been studied in patients with a history of pancreas inflammation (pancreatitis) or severe gastrointestinal disease (including severe gastroparesis, a condition that affects normal movement of the muscles in the stomach). It should not be used in combination with Mounjaro or a GLP-1 receptor agonist. The safety and effectiveness of coadministration of Zepbound with other medications for weight management have not been established.

Zepbound should not be used in patients with a history of severe allergic reaction to tirzepatide (its active ingredient) or to any of its other ingredients. Patients should stop Zepbound immediately and seek medical help if a severe allergic reaction is suspected. Zepbound also contains warnings for inflammation of the pancreas (pancreatitis), gallbladder problems, hypoglycemia (blood sugar that is too low), acute kidney injury, diabetic retinopathy (damage to the eye’s retina) in patients with type 2 diabetes mellitus and suicidal behavior or thinking. Patients should discuss with their health care provider if they have symptoms of pancreatitis or gallstones. If Zepbound is used with insulin or a medication that causes insulin secretion, patients should speak to their health care provider about potentially lowering the dose of these other medicines to reduce the risk of hypoglycemia. Health care providers should monitor patients with kidney disease, diabetic retinopathy and depression or suicidal behaviors or thoughts.

Zepbound received Priority Review and Fast Track designations for this indication.

The FDA granted this approval to Eli Lilly and Co.

NEWARK, DE - It is anticipated that the global pharmacy automation market would grow from US$ 6.1 billion in 2023 to US$ 13.3 billion by 2033. From 2023 to 2033, the market is anticipated to grow at a compound annual growth rate of 8.1%.

Robotic systems automate several physical tasks involved in pharmacy operations, such as dispensing medications, packaging prescriptions, and transporting medications throughout the pharmacy. This enables pharmacists to focus on more clinical tasks, such as patient counseling and medication management.

Artificial intelligence (AI) and machine learning (ML) are increasingly used in pharmacy automation systems for a wide range of tasks in the pharmacy, including prescription filling, inventory management, and patient counseling. For example, AI-powered prescription filling systems can automatically fill prescriptions accurately and quickly, reducing the risk of human error.

Cloud-based systems are more affordable and easier to implement than traditional on-premises systems. They also offer greater flexibility and scalability, making them a good option for pharmacies of all sizes, stimulating the adoption of cloud-based pharmacy automation systems.

"Interoperability allows pharmacy automation systems to communicate with other systems, such as electronic health records (EHRs) and laboratory information systems (LISs). This can improve the efficiency of pharmacy operations and reduce the risk of errors, increasing focus on interoperability between pharmacy automation systems and other healthcare IT systems," opines Sabyasachi Ghosh Associate Vice President at Future Market Insights (FMI).

Key Takeaways:

• The global pharmacy automation market is estimated to register a CAGR of 8.1%, reaching a valuation of US$ 13.3 billion by 2033.
• The market grew at a CAGR of 10.2% during the historical period from 2018 to 2022.
• The United States is anticipated to dominate the global market by registering an 8.3% CAGR during the forecast period.
• The market in China is anticipated to progress at a CAGR of 8.7% through 2033.
• The market in Japan is expected to secure a CAGR of 9.3% during the forecast period.

Key Players and Strategies for Success in the Pharmacy Automation Market

In recent years, there has been a surge in investments and collaborations within the industry with venture capital firms and businesses. These strategic partnerships and financial investments aim to accelerate research and development, scale production, and expand market reach.

Recent Developments in the Pharmacy Automation Market:

• In 2023, Omnicell launched its new specialty pharmacy services offering to help health systems establish and optimize specialty pharmacy programs. This service includes a suite of pharmacy automation solutions, such as robotic dispensing systems and cloud-based inventory management software.
• In 2021, BD launched its new AutoLink IV compounding system. This system automates the compounding of intravenous (IV) medications, reducing the risk of errors and improving the efficiency of pharmacy operations.
• In 2022, Parata Systems launched its new RxFill 360 dispensing system. This system uses AI and robotics to automate prescription filling, from order entry to labeling.

Key Players:

• Becton
• Cerner Corporation
• Parata Systems LLC
• Yuyama Co. Ltd
• PerceptiMed Inc
• McKesson Corporation
• Capsa Solutions LLC
• Omnicell Inc
• Dickinson and Company
• Arxium Inc
• Scriptpro LLC
• Swisslog Holdings AG
• Rxsafe LLC

Pharmacy Automation Market Segmentation:

By Product:

• Medication Dispensing Systems
• Automated Medication Compounding Systems
• Packaging and Labeling Systems
• Storage and Retrieval Systems
• Tabletop Tablet Counters

By End-use Sector:

• Inpatient Pharmacies
  • Acute Care Settings
  • Long Term Care Facilities
• Outpatient Pharmacies
  • Outpatient/Fast Track Clinics
  • Hospital Retail Settings
• Pharmacy Benefit Management Organization and Mail Order Pharmacies
• Retail Pharmacies

By Region:

• North America
• Latin America
• Western Europe
• Eastern Europe
• Asia Pacific Excluding Japan (APEJ)
• Japan
• Middle East & Africa

NEW HAVEN, CT - BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced an update on the National Institute on Drug Abuse (NIDA)-funded trial evaluating BXCL501 (sublingual dexmedetomidine) as a potential treatment for opioid use disorder (OUD).

BioXcel Therapeutics is supplying BXCL501 for an ongoing 4-arm, 160-patient trial that is enrolling patients who have been predominantly exposed to fentanyl and/or predominantly exposed to fentanyl adulterated or associated with xylazine (FAAX), which has been designated an emerging threat by the White House Office of National Drug Control Policy¹. NIDA has requested Columbia University, the trial coordinator, to add a fourth site to target trial completion in 2024. After this time, BioXcel Therapeutics plans to seek FDA feedback on potential registrational paths.*

According to NIDA, xylazine has been linked to an increasing number of overdose deaths nationwide in the evolving drug addiction and overdose crisis. Studies show people exposed to xylazine often knowingly or unknowingly used it in combination with other drugs, particularly illicit fentanyl.² Recently, the Biden administration requested $46 billion in its fiscal 2024 National Drug Control Budget³ to address the opioid epidemic, while opioid settlements reached between U.S. state and local governments and the 14 major pharmaceutical opioid manufacturers, distributors, and retailers have aggregated between $51 billion and nearly $55 billion.⁴

“We have long known that the locus coeruleus drives various opioid withdrawal symptoms⁵ but have lacked access to a sublingual formulation of dexmedetomidine, one of the most potent and selective alpha 2-adrenergic receptor agonists available, as a treatment option,” said Dr. Sandra Comer, Principal Investigator of the trial and Professor of Neurobiology in the Department of Psychiatry at Columbia University. “With BXCL501, we are excited about the potential to treat patients who are physically dependent on illicit and prescription opioids. We believe dexmedetomidine might be particularly helpful in treating withdrawal symptoms in patients who are dependent on fentanyl and/or fentanyl adulterated with xylazine.”

Between June 2020 and January 2021, Columbia University enrolled patients in the Company’s RELEASE trial — a multicenter, randomized, double-blind, placebo-controlled, ascending-dose Phase 1b/2 trial designed to evaluate the safety, pharmacokinetics, tolerability, and efficacy of BXCL501 administered twice daily for seven days — in patients experiencing opioid withdrawal symptoms. In March 2021, BioXcel Therapeutics announced RELEASE topline results. BXCL501 was generally well tolerated, with no severe or serious adverse events reported across all doses evaluated (30 mcg, 60 mcg, 90 mcg, 120 mcg, 180 mcg, and 240 mcg). After further post-hoc analysis, a peer-review article published in the American Journal of Drug and Alcohol Abuse in January 2023 ⁶ reported that the 240 mcg BID dose (480 mcg per day) was well tolerated, demonstrated statistically significant reduction in both Clinical Opiate Withdrawal Scale (COWS) and Subjective Opiate Withdrawal Scale (SOWS), and demonstrated a greater completion of treatment among enrolled patients, 87% of whom had been exposed to fentanyl. In August 2022, the Company announced an NIH NIDA grant to Columbia University to support further studies of BXCL501 for the treatment of OUD.

“While BXCL501 has already demonstrated statistical significance in patients exposed to fentanyl, this current study has a high proportion of patients exposed to FAAX and is comparing 180 mcg and 240 mcg BID doses to both placebo and the standard of care, lofexidine,” said Robert Risinger, M.D., Chief Medical Officer, Neuroscience of BioXcel Therapeutics. “BXCL501 is one of the only potential treatments being studied in this patient population and represents an important potential option to help address the growing OUD crisis.”

The BXCL501 OUD trial is supported by the National Institute on Drug Abuse of the National Institutes of Health (NIH) under award number UG3DA056247.

*In 2017, the U.S. federal government determined that a public health emergency under the Public Health Service Act for the opioid crisis existed, and this determination was recently renewed for 90 days in September 2023, although such public health emergency is independent from any public health emergency determined under the Federal Food, Drug, and Cosmetic Act. A separate determination under the act has not been issued and would be a prerequisite for FDA to declare that circumstances exist justifying emergency use of drugs to address the public health emergency, which must occur before FDA is authorized to issue emergency use authorizations for OUD drugs. The Company may consider advocating for such determination under the Federal Food, Drug and Cosmetic Act, as well as a declaration from the government that drugs targeting OUD are eligible for the emergency use authorization path to market, though they are not currently permitted under the law to be authorized pursuant to this pathway today.

IRVING, TX – Vizient, Inc. appreciates the Centers for Medicare and Medicaid Services (CMS) for finalizing its rule outlining how the agency plans to restore payments to hospitals that had reimbursement unlawfully reduced for drugs purchased through the 340B Drug Pricing Program from 2018 through a majority of 2022.

Vizient is pleased impacted 340B hospitals will be repaid through a one-time lump sum payment in early 2024. However, we are deeply disappointed with the agency's decision to maintain budget neutrality for the years the cuts were in effect. As Vizient previously iterated, hospitals should not have to endure reduced payments as a result of the agency's unlawful policies.

On November 2, 2023, in light of the Supreme Court’s decision in American Hospital Association v. Becerra (142 S. Ct. 1896 (2022)) and the district court’s remand to the agency, the Centers for Medicare & Medicaid Services (CMS) issued a final rule outlining the remedy for the invalidated OPPS 340B-acquired drug payment policy for Calendar Years 2018-2022. CMS is publishing this final rule to remedy the payment rates the Court held were invalid. Aspects of this finalized policy will affect nearly all hospitals paid under the OPPS.

This fact sheet discusses the provisions of the final rule (CMS- 1793-F), which can be downloaded at https://www.federalregister.gov/documents/current.

Background

Section 340B of the Public Health Service Act (340B) allows participating hospitals and other providers to purchase certain covered outpatient drugs or biologicals (hereinafter referred to collectively as “drugs”) from manufacturers at discounted prices. Prior to 2018, the Medicare payment rate for Part B covered outpatient drugs provided in outpatient hospitals was generally the statutory default of average sales price (ASP) plus 6%. In the CY 2018 OPPS/ASC final rule that was finalized in 2017, CMS adjusted the payment rate for 340B drugs to ASP minus 22.5% to reflect more accurately the actual costs incurred by 340B hospitals when acquiring 340B drugs. This rate applied from CY 2018 through approximately the third quarter of CY 2022. To comply with statutory budget neutrality requirements under the OPPS, CMS made a corresponding increase to payments to all hospitals (340B hospitals and non-340B hospitals) for non-drug items and services, which was in effect from CY 2018 through CY 2022.

On June 15, 2022, the Supreme Court unanimously ruled that the differential payment rates for 340B-acquired drugs were unlawful because, prior to implementing the rates, HHS failed to conduct a survey of hospitals’ acquisition costs under the relevant statute.

On September 28, 2022, the District Court for the District of Columbia vacated the differential payment rates for 340B-acquired drugs going forward. As a result, all CY 2022 claims for 340B-acquired drugs paid on or after September 28, 2022, were paid at the default rate (generally ASP plus 6%).

In the CY 2023 OPPS/ASC final rule, CMS finalized a general payment rate of ASP plus 6% for drugs acquired through the 340B Program, consistent with the agency’s policy for drugs not acquired through the 340B program. As required by statute, CMS implemented a 3.09% reduction to the payment rates for non-drug items and services to achieve budget neutrality for the 340B drug payment rate change for CY 2023. This budget neutrality change ensured the CY 2023 OPPS conversion factor was equivalent to the conversion factor that would have been in place had the 340B drug payment policy never been implemented.

On July 7, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule outlining the proposed remedy for the 340B-acquired drug payment policy for Calendar Years 2018-2022. The public comment period ended on September 11, 2023.

Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022

Lump Sum Payments to Affected Providers for 340B-Acquired Drugs

In the final rule, CMS is finalizing a policy to make an additional payment to affected providers for 340B-acquired drugs as a one-time lump sum payment. CMS estimates that for CY 2018 through the approximate third quarter of 2022, certain OPPS 340B providers received $10.6 billion less in 340B drug payments than they would have without the 340B policy. However, many CY 2022 340B drug claims have been processed, or reprocessed through standard claims processing, at the higher default payment rate since the 340B payment policy was vacated on September 27, 2022. As a result, affected 340B providers have already received from Medicare and beneficiaries $1.6 billion of the $10.6 billion that would otherwise have had to be remedied through these reprocessed claims. For the remaining $9.0 billion owed to affected 340B providers for claims covering CYs 2018 through 2022, CMS is making a one-time lump-sum payment to each 340B-covered entity hospital that was paid less due to the now-invalidated policy. The final rule contains the calculations of the amounts owed to each of the approximately 1,700 affected 340B covered entity hospitals.

Beneficiary Copayments

Beneficiary copayments make up approximately 20% of the payments affected 340B covered entity hospitals did not receive due to the 340B payment policy. Because CMS is structuring the remedy as a lump-sum remedy payment, providers are not able to bill beneficiaries for that cost sharing. To account for that fact, and to ensure that affected 340B providers are put in as close to the same position as if the 340B payment policy had never existed, Medicare is accounting for beneficiary cost sharing within the one-time lump sum payment to affected hospitals. Consequently, affected 340B covered entity hospitals may not bill beneficiaries for coinsurance on remedy payments.

Prospective Offset for Higher Payments for Non-Drug Items and Services from CY 2018-2022

As part of this remedy, CMS is maintaining budget neutrality as required by statute. As described above, CMS finalized the 340B policy for CY 2018 in 2017 in a budget neutral manner that included increasing payments for non-drug items and services; this payment increase was in effect from CY 2018 through CY 2022. CMS estimates that hospitals were paid $7.8 billion more for non-drug items and services during this time period than they would have been paid in the absence of the 340B payment policy. Because CMS is now making additional payments to affected 340B covered entity hospitals to pay them what they would have been paid had the 340B policy never been implemented, CMS is making a corresponding offset to maintain budget neutrality as if the 340B payment policy had never been in effect. To carry out this required $7.8 billion budget neutrality adjustment, CMS will reduce future non-drug item and service payments by adjusting the OPPS conversion factor by minus 0.5% starting in CY 2026. We selected minus 0.5% in an effort to minimize the financial burden of this required offset on impacted hospitals.  CMS originally proposed for the offset to start in CY 2025 but sought comment on an alternative start date such as CY 2026. Many commenters argued for a CY 2026 start date to give hospitals additional time to make necessary arrangements given the financial challenges of unprecedented workforce shortages, inflation, supply chain disruptions, eroding margins, cost increases due to increases in supplies and staffing costs and the lingering effects of the COVID-19 Public Health Emergency. After consideration of the comments received, CMS is finalizing for the prospective offset to start for CY 2026. CMS will continue this adjustment until the full $7.8 billion is offset, which CMS estimates to be 16 years.

For Medicare Advantage payment, more information is in the Hospital Outpatient Prospective Payment System Update on Payment Rates for Drugs Acquired through the 340B Program - Informational for MAOs memorandum that was issued by CMS on December 20, 2022. 

Beneficiary copayments for non-drug items and services will decrease slightly in upcoming years as a result of the prospective offset to the OPPS conversion factor.

FORT WORTH, TX - Omnicell, Inc. (Nasdaq: OMCL), a leader in transforming the pharmacy care delivery model, today announced that Kentucky-based Baptist Health has selected Omnicell’s Central Pharmacy Dispensing Service in an effort to address labor challenges and improve clinical and financial outcomes.

Labor shortages, disconnected care settings, and manual processes continue to impact patient care for many healthcare providers and prevent clinicians from operating at the top of their license.

Baptist Health is one of the latest health systems to adopt Omnicell’s Central Pharmacy Dispensing Service, which is expected to help enhance safety and dispensing accuracy while streamlining workflows through a combination of advanced robotics, dispensing optimization tools, and remote and onsite experts. This comprehensive solution is designed to automate and optimize pharmacy labor and workflows, leading to pharmacists spending on average 75 percent less time on dispensing tasks.¹

“We selected Omnicell’s robotics and services for our Central Pharmacy Services Center in an effort to help alleviate staffing challenges while focusing on improving quality, patient safety, and efficiency,” said Nilesh Desai, Chief Pharmacy Officer at Baptist Health. “We’re excited about the opportunity to advance further toward our vision of a fully integrated and highly automated pharmacy solution.”

We believe automating central pharmacy tasks is critical to achieving the Autonomous Pharmacy, an industry-defined vision to replace manual, error-prone activities with automated processes that are intended to be safer and more efficient.

“Baptist Health has been a leader in embracing the industry vision of a fully autonomous pharmacy,” said Alex Pratt, senior vice president and chief growth officer for Omnicell. “The addition of these Advanced Services should help them move closer to that vision while also helping to enable them to achieve their goals of optimized clinical and financial outcomes.”

Learn more about Omnicell’s Advanced Services and the transformation of pharmacy care at omnicell.com.

RAHWAY, NJ - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). The approval was based on results from the Phase 3 KEYNOTE-966 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in the study’s primary endpoint of overall survival (OS), reducing the risk of death by 17% (HR=0.83 [95% CI, 0.72-0.95]; one-sided p=0.0034) compared to chemotherapy alone at the trial’s pre-specified final analysis for OS. Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone. This approval marks the sixth indication for KEYTRUDA in gastrointestinal cancers.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.

“Cancers of the biliary tract can be highly aggressive tumors, underscoring the need for additional treatment options for the growing number of patients facing this challenging disease,” said Dr. Robin Kate Kelley, professor of clinical medicine in the division of hematology/oncology, University of California, San Francisco. “Today's approval of pembrolizumab in combination with chemotherapy offers patients with locally advanced unresectable or metastatic biliary tract cancer a new immunotherapy regimen that has demonstrated the potential to help these patients live longer.”

“Many patients with biliary tract cancer are diagnosed with locally advanced or metastatic disease, at which point they are not eligible for surgery and face poor survival outcomes with limited treatment options,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “With this approval, Merck is proud to offer a new treatment option to certain patients with locally advanced unresectable or metastatic biliary tract cancer, and their healthcare providers, that has shown an overall survival benefit compared to chemotherapy alone.”

Study design and additional data supporting the approval

KEYNOTE-966 is a multicenter, double-blind, randomized, placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT04003636) evaluating KEYTRUDA in combination with gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic BTC who had not received prior systemic therapy in the advanced disease setting. The trial enrolled 1,069 patients.

Patients were randomized (1:1) to KEYTRUDA (200 mg) on Day 1 plus gemcitabine (1,000 mg/m²) and cisplatin (25 mg/m²) on Day 1 and Day 8 every three weeks (n=533), or placebo on Day 1 plus gemcitabine (1,000 mg/m²) and cisplatin (25 mg/m²) on Day 1 and Day 8 every three weeks (n=536). Study medications were administered via intravenous infusion. Treatment continued until unacceptable toxicity or disease progression. For KEYTRUDA, treatment continued for a maximum of 35 cycles (or approximately 24 months). For gemcitabine, treatment could be continued beyond eight cycles, while for cisplatin, treatment could be administered for a maximum of eight cycles. Administration of KEYTRUDA with chemotherapy was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered by the investigator to be deriving clinical benefit. Assessment of tumor status was performed at baseline and then every six weeks through 54 weeks, followed by every 12 weeks thereafter.

The major efficacy outcome measure was OS. Additional efficacy outcome measures were progression-free survival (PFS), objective response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review (BICR) according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ.

At the trial’s pre-specified final analysis for PFS and ORR, KEYTRUDA plus chemotherapy reduced the risk of disease progression or death by 14% (HR=0.86 [95% CI, 0.75-1.00]) compared to chemotherapy alone. Median PFS was 6.5 months (95% CI, 5.7-6.9) for KEYTRUDA plus chemotherapy versus 5.6 months (95% CI, 5.1-6.6) for chemotherapy alone; however, this result did not reach statistical significance at this analysis. The ORR for KEYTRUDA plus chemotherapy was 29% (95% CI, 25-33), with a complete response (CR) rate of 2.1% (n=11) and a partial response (PR) rate of 27% (n=142), and the ORR for chemotherapy alone was 29% (95% CI, 25-33), with a CR rate of 1.3% (n=7) and a PR rate of 27% (n=146). At the trial’s pre-specified final analysis for OS, median DOR was 8.3 months (95% CI, 6.9-10.2) for KEYTRUDA plus chemotherapy (n=156) versus 6.8 months (95% CI, 5.7-7.1) for chemotherapy alone (n=152).

The median duration of exposure to KEYTRUDA was six months (range, 1 day to 28 months). KEYTRUDA was discontinued due to adverse reactions in 15% of patients. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA (≥1%) was pneumonitis (1.3%). Adverse reactions leading to interruption of KEYTRUDA occurred in 55% of patients; the most common adverse reactions or laboratory abnormalities leading to interruption of KEYTRUDA (≥2%) were decreased neutrophil count (18%), decreased platelet count (10%), anemia (6%), decreased white blood count (4%), pyrexia (3.8%), fatigue (3.0%), cholangitis (2.8%), increased alanine aminotransferase (ALT) (2.6%), increased aspartate aminotransferase (AST) (2.5%) and biliary obstruction (2.3%).

In the KEYTRUDA plus chemotherapy versus placebo plus chemotherapy arms, there was a difference of ≥5% incidence in adverse reactions between patients who received KEYTRUDA versus placebo for pyrexia (26% vs. 20%), rash (21% vs. 13%), pruritus (15% vs. 10%) and hypothyroidism (9% vs. 2.6%). There were no clinically meaningful differences in incidence of Grade 3-4 toxicity between arms.

There was a difference of ≥5% incidence in laboratory abnormalities between patients who received KEYTRUDA plus chemotherapy versus placebo plus chemotherapy for decreased lymphocytes (69% vs. 61%). There were no clinically meaningful differences in incidence of Grade 3-4 toxicity between arms.

Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following indications:

Adult patients with:

• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
• active psoriatic arthritis;
• moderately to severely active Crohn’s disease; and
• moderately to severely active ulcerative colitis.

Pediatric patients 6 years of age and older with:

• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and
• active psoriatic arthritis.

Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

“Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases,” said Nikolay Nikolov, M.D., director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. “Today’s approval could have a meaningful impact for patients managing their disease.”

Biological products include medications for treating many serious illnesses and chronic health conditions. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). An interchangeable biosimilar is a biosimilar that has been shown to meet other requirements under the law and may be substituted for the reference product without consulting the prescriber. The substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state, a practice commonly called “pharmacy-level substitution” — similar to how generic drugs are substituted for brand name drugs.

All biological products are approved only after they meet the FDA’s rigorous approval standards. This means health care providers and patients can expect the same safety and effectiveness from both a biosimilar and an interchangeable biosimilar, just as they would for a reference product. Biosimilar and interchangeable biosimilar products may cost less than the brand-name medicine.

“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research. “This approval can empower patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

The FDA’s approval of Wezlana is based on a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency (i.e., safety and effectiveness). This evidence included comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data. The evidence also demonstrated that Wezlana met the other legal requirements to be interchangeable with Stelara at the pharmacy level.

Like Stelara, the most serious known side effect of Wezlana is infection. The most common adverse reactions with ustekinumab products are nasopharyngitis, upper respiratory tract infection, headache, fatigue, nausea, vomiting, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis, abdominal pain, influenza, fever and diarrhea.

The labeling for Wezlana, like Stelara, contains a warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization. There is also a warning that some malignancies, hypersensitivity reactions, and cases of Posterior Reversible Encephalopathy Syndrome  have been reported in patients who received Wezlana in clinical studies. Wezlana must be dispensed with a patient Medication Guide that describes important information about its uses and risks.

The FDA granted the approval of Wezlana to Amgen, Inc.

NASHVILLE, TN – In a show of unity and determination, pharmacy staff at CVS and Walgreens stores across the nation have embarked on a three-day walkout to demand fair wages and improved working conditions. The walkout, which began this morning, is expected to have a significant impact on both pharmacy giants as employees seek better compensation and benefits.

PARIS, FRANCE - Sanofi, a global pharmaceutical giant, has unveiled a comprehensive update to its "Play to Win" strategy, highlighting a renewed focus on research and development (R&D) investments, a separation of its Consumer Healthcare Business, and ongoing cost-saving initiatives. These strategic moves aim to accelerate innovation and long-term growth while enhancing shareholder value.