FDA approves first bone marrow stimulator

Washington -- The U.S. Food and Drug Administration says it has approved Nplate (romiplostim), the first product that directly stimulates bone marrow platelet production.

The FDA said the new drug will be used to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.

The condition, which usually develops in adults, is known as chronic immune thrombocytopenic purpura, or ITP, a disease that results in a low number of platelets, the blood components that help with clotting.

In patients with chronic ITP, the immune system is believed to destroy platelets and the patient's bone marrow is often unable to compensate for that loss, the FDA said.

"This product is important in that it offers a new approach to the treatment of patients with an uncommon blood disorder who are often very ill," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

Nplate is manufactured by Amgen Inc. of Thousand Oaks, Calif.

Copyright 2008 by United Press International.