EMA, Safety

EMA sounds its own safety alarm for Pfizer blockbuster, but they’re also not forcing a limit on dosing — yet

The European Medicines Agency has issued a formal warning for patients and physicians to stick with the recommended dose of Xeljanz for treating rheumatoid arthritis and to watch out for potentially lethal blood clots.

Pfizer has been bedeviled by a clear safety signal on their blockbuster JAK inhibitor, flagging the risk of blood clots and death for the twice daily 10 mg dose of Xeljanz, which is authorized at 5 mg twice a day for RA.

While full results are awaited, EMA is recommending that healthcare professionals monitor patients for signs and symptoms of blood clots in the lungs. Patients should not stop or change their dose of Xeljanz without talking to their doctor. Patients should seek medical attention immediately if they experience symptoms such as difficulty breathing, pain in the chest or upper back and coughing up blood.

But it’s also not as simple as all that. The EMA notes that there are a number of ongoing clinical trials using the 10 mg dose, which is the approved amount for use in treating ulcerative colitis. The JAK field has been constricted by safety worries, which held back an initial approval for years after the FDA offered a green light. The latest move follows a safety alarm from the FDA, which was clearly startled by the evidence of blood clots and death from a required follow-up study to their accelerated approval.

Neither regulatory group has demanded that Pfizer yank the 10 mg dose, with both operations saying they were waiting for the full set of data before taking action.

The problems with Xeljanz may well completely disrupt the multibillion-dollar market for RA and related diseases, with more JAK drugs angling to offer a better safety profile. 

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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