Amgen's Nplate Meets Primary Endpoint

Amgen reported results from a second Phase III study in which Nplate increased and sustained platelet counts in adult patients with chronic immune thrombocytopenic purpura (ITP) — an autoimmune disorder characterized by low platelet counts in the blood — whose spleens had not been removed.

The randomized, double-blind, placebo-controlled study met its primary endpoint with 61 percent of Nplate-(romiplostim) treated patients achieving durable platelet response compared with 4.8 percent of patients receiving placebo. Overall response was 87.8 percent in Nplate-treated patients compared with 14.3 percent of patients in the placebo group, Amgen said.

Nplate patients also taking concurrent ITP medications, such as corticosteroids, were able to reduce or discontinue these medications.

Amgen has filed for regulatory approval of Nplate in the U.S., European Union, Australia and Canada.