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Eltrombopag gets FDA priority review

GlaxoSmithKline was granted a priority review for its drug Promacta by the US Food and Drugs Administration on March 3.

GlaxoSmithKline (GSK) was granted a priority review for its drug Promacta by the US Food and Drugs Administration (FDA) on March 3.

Promacta (eltrombopag) could be the first oral thrombocytopenic (TPO) receptor for short-treatment of patients with chronic idiopathic thrombocytopenic purpura (ITP).

Now the priority has been given, the FDA is expected to render a decision on the New Drug Application (NDA) for the investigational compounds within six months.

Dr Paolo Paoletti, senior vice president of the Oncology Medicine Development Centre at GSK, said: "The FDA designation of our submission for priority review is very encouraging and brings us closer to offering physicians and their patients eltrombopag."

"Our goal for eltrombopag is to make available a targeted therapy in oral form for patients to help raise their platelet counts without having to suppress the immune system."

Europe could benefit from this new medication as GSK plans to make a Marketing Authorisation Application (MAA) in 2008 for eltrombopag, which in the EU is marketed as Revolade.

Eltrombopag is now also being considered as a potential long-term treatment for chronic ITP in addition to thrombocytopenia associated with hepatitis C.

3rd March 2008

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