Regulatory Focus™ > News Articles > Pfizer Withdraws Indication for RA Drug After It Fails to Complete Required Study

Pfizer Withdraws Indication for RA Drug After It Fails to Complete Required Study

Posted 07 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) said Pfizer is withdrawing an indication for its rheumatoid arthritis (RA) drug Celebrex after Pfizer indicated it would not be able to complete a mandated postmarketing study to verify the new indication.

Celebrex had received approval for its indication to treat familiar adenomatous polyposis (FAP) in 1999 under FDA's accelerated approval pathway. The inherited condition causes polyps to form in the large intestine, often causing malignant, cancerous growths if left untreated. Under the terms of the accelerated approval, Pfizer was charged with conducting a postmarketing study on the target population, which was intended to "verify clinical benefit."

"The study was never completed," remarked FDA in its 7 June 2012 Federal Register posting, and Pfizer requested the withdrawal of the FAP indication in a 3 February 2011 request to FDA. Pfizer said it had waived its right to a hearing to contest the withdrawal, but noted it had not withdrawn the indication as the result of "any new efficacy or safety data."

The drug is also approved for a wide range of arthritis treatments, including osteoarthritis and rheumatoid arthritis. Only Celebrex's FAP indication is affected by the announcement.

Read more:

FDA - Pfizer, Inc.; Withdrawal of Approval of Familial Adenomatous Polyposis Indication for CELEBREX

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