Amgen gets FDA approval for Nplate

THOUSAND OAKS, Calif. The Food and Drug Administration has approved Nplate, a new drug from Amgen for treating the blood clotting disorder thrombocytopenia in adults, Amgen announced Friday.

Thrombocytopenia is a serious autoimmune disorder in which people have low platelet counts that can cause dangerous blood loss because the blood fails to clot. Chronic immune thrombocytopenic purpura, also known as chronic ITP, affects about 60,000 adults in the United States, according to Amgen, and the FDA considers it an unmet need.

“Until now, patients suffering from chronic ITP have had limited available treatment options, many of which are often unsuitable for long-term use due to side effects and tolerability issues,” said David Kuter, chief of hematology at Massachusetts General Hospital in Boston. “Nplate represents the first long-term treatment for chronic ITP patients, providing a new treatment approach for this chronic disease.”