Delay Seen for Amgen Drug

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Amgen Inc. said late Tuesday that the U.S. Food and Drug Administration plans to delay by three months a decision on whether to approve the company’s experimental blood clotting drug

The drug romiplostim is used to treat a disorder called chronic immune thrombocytopenic purpura, in which the blood does not clot properly. The delay will enable the the agency to review additional data it requested from Amgen.

The FDA had been expected to make a decision by April 23.

“Amgen believes the data contained in our registrational clinical studies paired with our proposed comprehensive risk management program, together support approval by the FDA, providing ITP patients with a potential new treatment option,” the Thousand Oaks-based company said in the statement.

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