Expected US approval of Amgen

The Food and Drug Administration has delayed its decision on approving US biotechnology major Amgen's Nplate (romiplostim), an investigational thrombopoietin mimetic peptibody, under review for thrombocytopenia in adult patients with chronic immune thrombocytopenic purpura. Earlier this year (Marketletter March 17), an FDA panel of expert advisers voted unanimously to clear the agent. Although non-binding, the agency usually follows their advice. Amgen would not reveal the reason for the delay.