FDA delays approval of platelet-increasing therapy

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The FDA has informed Amgen that the action date for the agency’s priority review of its biologics license application (BLA) for romiplostim to treat thrombocytopenia in adult patients with chronic immune thrombocytopenic purpura (ITP) has been rescheduled from April 23 to July 23.

Romiplostim was subject to an FDA advisory panel hearing about a month ago, when the panel unanimously voted in favor of the drug’s approval.

“Amgen provided to the FDA a robust risk-management program designed to optimize appropriate use of romiplostim in ITP patients. The FDA considers this additional information to be a major amendment to the romiplostim BLA, which triggers a three-month review extension according to the current PDUFA rules,” the Thousand Oaks, Calif.-based Amgen said.

The company said that it is confident that “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.”