Despite FDA concerns, Pfizer's Xeljanz wins unanimous AdComm backing in ulcerative colitis

Pfizer sign
Pfizer is looking for its third indication for Xeljanz. (Tracy Staton)

Pfizer just got some backup on its quest to snag a nod for ulcerative colitis med Xeljanz.

On Thursday, the FDA’s GI drugs advisory committee voted unanimously to approve the drug, even recommending a green light for a higher 10-mg dose.

RELATED: Pfizer's Xeljanz shores up case for ulcerative colitis expansion

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Regulators had expressed concerns about the larger dose’s safety, supporting only a 5-mg dose, Leerink Partners analyst Geoffrey Porges wrote in a Friday note to clients. But now, the vote “may force their hand in approving a broader label than we originally anticipated,” he said.

A 10-mg dose had been previously discontinued in both rheumatoid arthritis and psoriatic arthritis, Xeljanz’s other indications, because of serious side effects. But ulcerative colitis is notoriously tough to tackle, Porges pointed out, and Pfizer’s seeking the 10-mg approval only for the most difficult-to-treat patients.

RELATED: Pfizer takes on Novartis, Lilly with Xeljanz psoriatic arthritis approval

The AdComm outcome isn’t just good news for Pfizer, which is looking to expand its blockbuster further after December’s psoriatic arthritis nod. It’s also good news for would-be competitors in the JAK inhibitor class, such as AbbVie’s upadacitinib and Gilead’s filgotinib, Porges figures.

“We regard this vote as an endorsement of the development plans of the many other companies and products advancing in this field, and increases their likelihood of approval, in our view,” he wrote.

But of course, despite the AdComm enthusiasm, it’ll be up to the FDA to decide whether Xeljanz—and its future rivals—see the ulcerative colitis market.

“The proof of this process is only the final regulatory decision, and historically the FDA’s caution in this indication may still limit the label, or dosing, granted to Xeljanz,” Porges cautioned clients.

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