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Pfizer’s Xeljanz Could See Narrower Label And New REMS Due To CV And Malignancy Risks

 
• By Sue Sutter

The US FDA will ponder its regulatory options now that final data are in from a long-term postmarketing study showing tofacitinib is associated with a higher rate of major adverse cardiovascular events and malignancies compared with TNF-inhibitors.

x-ray hands, rheumatoid arthritis
A Xeljanz study in high-risk rheumatoid arthritis patients has raised safety concerns. • Source: Shutterstock

The US Food and Drug Administration will weigh its regulatory its options for Pfizer Inc.’s Xeljanz (tofacitinib) in light of cardiovascular and malignancy risks identified in a long-term, postmarketing safety trial of the JAK-inhibitor in rheumatoid arthritis patients.

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More from United States

New US FDA Roadmap Moves Closer To Animal Testing Alternatives

 
• By Bridget Silverman

New plan to encourage alternatives to animal testing seeks interagency cooperation to meet more aggressive targets for transformational change than the US FDA’s long-standing program.

HHS’ Kennedy Warns US FDA Staff Against ‘Agency Capture’ By Industry, Special Interests

 
• By Sue Sutter

HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By Cathy Kelly

Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

More from North America

Kennedy’s Comments On Novavax Delay Scientifically, Legally Inaccurate, Experts Say

 
• By Sarah Karlin-Smith

The HHS Secretary publicly acknowledged the unusual delay of Novavax's COVID-19 vaccine licensure, but his justification was neither scientifically accurate nor legally justifiable, experts said.

New Medicare Negotiation Program ‘Iterations’ Inevitable, Former CMS Official Blum Says

 
• By Cathy Kelly

Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.

US FDA Rare Disease Innovation Hub’s Goals Align With Trump, Leader Says

 
• By Sue Sutter

The hub’s goals of efficiency, centralization and coordination fit with the Trump Administration’s current focus for the FDA, Amy Comstock Rick, director of strategic coalitions, told the Biopharma Congress.