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US FDA Restricts JAK Inhibitors To Second-Line In Rheumatoid Arthritis Amid CV, Cancer, Mortality Risks

 
• By Derrick Gingery

Now that the analysis of Pfizer’s postmarketing trial for Xeljanz is complete, though, application reviews of other products will likely be completed. The Xelijanz study revealed elevated risk of heart-related events, cancer, blood clots and death, resulting in a class-wide indication restriction and a revised boxed warning.

rheumatoid arthritis x-ray image
A postmarket study of the rheumatoid arthritis drug Xeljanz lead the FDA to revise the boxed warning and limit its use. • Source: Alamy

Cardiovascular, cancer and other concerns forced the US Food and Drug Administration to limit the use of several JAK inhibitors to patients who cannot tolerate one or more TNF blockers.

Based on a review of safety data on Pfizer Inc.’s rheumatoid arthritis and ulcerative colitis drugs Xeljanz and Xeljanz...

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More from Post-Marketing Regulation & Studies

Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector

 
• By Mandy Jackson

Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.

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• By Sue Sutter

The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.

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• By Sarah Karlin-Smith

The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

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‘Missed Opportunity’: GSK Failed To Optimize Blenrep Dosage, US FDA Panel Says

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee said the benefit-risk of belantamab mafoditin for two second-line multiple myeloma indications is not favorable at the proposed dosages and raised concerns about applicability of trial results to US patients.

‘Unprecedented Story’: Revoked EU Marketing Authorization Fails To Thwart Translarna Sales

 
• By Francesca Bruce

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• By Bridget Silverman

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.