FDA decision on Amgen clotting drug delayed
NEW YORK, April 8 |
NEW YORK, April 8 (Reuters) - Amgen Inc (AMGN.O) said on Tuesday that U.S. health regulators have delayed by three months a decision on whether to approve its drug, romiplostim, for treatment of a disorder in which the blood does not clot properly.
The Food and Drug Administration decision date is now July 23, rather than April 23, Amgen said. The delay will enable the the agency to review additional information submitted by Amgen on the medicine for chronic immune thrombocytopenic purpura (ITP), a condition in which a low count of platelets in the blood hampers clotting.
A panel of FDA experts unanimously voted to recommend approval of romiplostim in March. (Reporting by Bill Berkrot)
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