FDA Rejects Incyte's Bid for Once-Daily Jakafi Approval
24 März 2023 - 11:39AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 24, 2023 06:24 ET (10:24 GMT)
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