Amgen said it has received notification from the US Food and Drug Administration (FDA) that the action date for FDA's priority review of Biologics License Application (BLA) for romiplostim for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenic purpura (ITP) has been extended to July 23, 2008. The original action date for the BLA was April 23, 2008.
Following the March 12 Oncologic Drugs Advisory Committee (ODAC) meeting, 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, Amgen said while issuing a statement on the Prescription Drug User Fee Act (PDUFA) date for romiplostim.
The ODAC unanimously voted to recommend approval of romiplostim for this indication. We look forward to continued productive discussions with the FDA. 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.