FDA Rejects Incyte's Bid for Once-Daily Jakafi Approval

By Colin Kellaher

Incyte Corp. said the U.S. Food and Drug Administration has turned away its proposed once-daily version of its blockbuster blood-cancer drug Jakafi.

The Wilmington, Del., biopharmaceutical company, which was seeking approval of extended-release Jakafi tablets to treat certain types of myelofibrosis, polycythemia vera and graft-versus-host disease, said the FDA issued a complete response letter, indicating the agency can't approve the application in its current form.

Incyte said the FDA acknowledged that the company's study underpinning the application met its objective of bioequivalence to the current twice-daily Jakafi based on area-under-the-curve parameters, but that the agency identified additional requirements for approval.

Incyte, which reported Jakafi revenue topping $2.4 billion last year, said it plans to meet with the FDA to determine appropriate next steps.

Under a long-running collaboration, Incyte markets the drug as Jakafi in the U.S., while Switzerland's Novartis AG markets it as Jakavi outside the U.S.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

March 24, 2023 06:24 ET (10:24 GMT)

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