FDA Approves Amgen Inc.'s Nplate Drug For The Fight Against ITP

By Alex Garrel
12:17, August 24th 2008
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FDA Approves Amgen Inc.'s Nplate Drug For The Fight Against ITP

On Friday, the Food and Drug Administration (FDA) gave its approval for Amgen Inc.'s drug called Nplate, therefore it will be made available for U.S. residents soon enough.

The administration acknowledged the efficiency and lack of risks associated with the use of the new drug, which can be used for treating a clotting disorder that causes massive bleeding.

According to the FDA, the way the injectable drug works is it stimulates bone marrow which then produces blood platelets; Nplate will be very useful for patients diagnosed with chronic immune thrombocytopenic purpura (ITP).

Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said the new drug is important because it provides an innovative approach to the treatment of the rare blood disorder.

Amgen Inc. said the costs of the Nplate treatment will probably be very close to the costs of "standard treatment regimens."

The FDA’s decision followed the failure of several other treatments which addressed the condition. Before the approval, two studies on 125 patients have been carried out over a six month period. From now on, the doctors who prescribe Nplate and the patients who benefit from the drug will have to be included in a special registry which will eventually provide long-term safety related information.

According to the company, there are currently around 60,000 U.S. adults suffering from chronic ITP. Starting from these numbers, certain analysts said the drug could generate revenues ranging from $66 million to $117 million in 2009.



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