EMA, Safety

Pfizer’s blockbuster safety issue jumps the Atlantic as EMA launches its own review of Xeljanz

Pfizer’s Xeljanz woes have spread to Europe.

After the FDA announced earlier this week that it is investigating the increased risk of blood clots and death linked to their blockbuster JAK inhibitor seen in a post-marketing study, the EMA says they’ll now make their own assessment on the safety of the drug.

“EMA is assessing the results of the study and will consider what regulatory action is needed,” the agency said in a statement sent to Endpoints News. The EMA added that patients should consult a doctor if they have any questions.

European regulators had proved much tougher than the FDA on Xeljanz, waiting until 2017 to approve the drug for rheumatoid arthritis after delaying the rollout for more safety data — 6 years after the FDA OK.

The drug entered the market with a black box warning of a higher risk of infections, but the pharma giant set off alarm bells when researchers said they were taking people off the 10 mg dose used in their assessment of the drug’s safety among patients with an added cardio risk after the trial monitors concluded that the drug was associated with higher rates of blood clots and death.

Both the FDA and EMA note that the recommended dose for Xeljanz in RA is 5 mg twice a day, but the drug is approved at 10 mg for ulcerative colitis. Eli Lilly also faced its own challenges after the FDA initially rejected its JAK inhibitor baricitinib, finally approving it as Olumiant last year at a lower dose than it had sought.

The new safety alert comes at a bad time for Pfizer, which is depending on rising sales of its blockbuster drug at a time when US lawmakers have been hammering hard against annual price hikes. Other JAKs are in the late-stage pipeline with their own claims on safety and efficacy that will now face further scrutiny.

On the other hand, any new RA therapy entering the field with a better safety profile will be looking at a seriously disrupted market.


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 45,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

Visit Endpoints Careers ->