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

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.

More from Post-Marketing Regulation & Studies

Global Regulators Consider Extending Pilot On Post-Approval CMC Changes After Positive Findings

 

Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.

Pharma Industry Wants Easier Access To England’s Revamped NHS Data Sharing System

 

The pharmaceutical industry was not sufficiently involved in designing updates to England’s health data infrastructure, leading to a “misalignment” between company needs and what is currently being delivered, according to the results of a survey by the Association of the British Pharmaceutical Industry.

US FDA In ‘First Stages’ Of Reconsidering Black Box For Antipsychotics

 

Patient advocates and sponsors want the US to reconsider a 20-year-old class warning against the use of antipsychotics in patients with dementia. The agency is weighing the issue, but also defending the current labels of newer agents.

Shorter Gene Therapy Postmarket Studies ‘On The Table’

 

Amid complaints about the challenges of following gene therapy patients for up to 15 years, OTP Director Nicole Verdun said the FDA is considering how to conduct long-term postmarket studies more efficiently.

More from Product Reviews

EMA Considers Whether Intrathecal Zolgensma Deserves Fast Tracking

 

Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.

Sponsors Of Two Orphans And An Acne Treatment To Defend Marketing Authorization Applications At EMA

 

Sponsors of three drugs that are in the final stages of the EU regulatory review cycle are due to make the case for marketing approval before the European Medicines Agency.

EU Marketing Approval Gap Between Lilly’s Donamemab and Eisai’s Leqembi Could Narrow

 

The European Medicines Agency is this week set to issue an opinion on whether pan-EU marketing should be granted to Lilly’s Alzheimer’s disease drug donanemab.