Shares of Celgene dipped this morning after the drug developer announced that the FDA would delay a decision on Revlimid for up to three months. The agency had been scheduled to make a decision on the anemia drug by October 7. Celgene officials said that the delay was linked to a request for more information, specifically the risk-management plan for the drug. Revlimid is similar to thalidomide, a drug that caused birth defects when originally released.
Celgene added that it is preparing to go ahead and ask the FDA for approval to use the drug for multiple myeloma. The biotech company based its NDA on a Phase II trial, convincing the FDA's advisory panel that it should start marketing prior to the completion of a Phase III trial. About a week ago Celgene temporarily suspended a Revlimid trial after finding an unusually high number of cases of blood clotting among patients.
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