FDA Grants Priority Review for PROMACTA(R) (el...( PHILADELPHIA and LONDON March 3 /...),Health

PHILADELPHIA and LONDON, March 3 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK; LSE) today announced that the United States Food and Drug Administration has granted Priority Review for PROMACTA(R) (eltrombopag) for the short-term treatment of patients with chronic idiopathic thrombocytopenic purpura (ITP). PROMACTA is an investigational, once-daily oral treatment that induces the production of cells in the bone marrow to generate platelets, which are critical in minimizing the incidence of bleeding in chronic ITP.

If approved, PROMACTA would be the first oral thrombopoeitin (TPO) receptor agonist for the short-term treatment of previously treated patients with chronic ITP to increase platelet counts and reduce bleeding.

"Our goal for PROMACTA 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," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK. "The FDA designation of our submission for priority review is very encouraging and brings us closer to offering physicians and their patients PROMACTA."

The priority review designation means FDA is expected to make a decision on the NDA for the investigational compound within six months of the submission.

In pivotal studies, the most common adverse events observed in patients taking PROMACTA were headache, nausea, nasopharyngitis, diarrhea and vomiting.

GSK also plans to submit a Marketing Authorization Application (MAA) for eltrombopag in the treatment of chronic ITP in Europe in 2008 where it will be marketed as REVOLADE(R). The compound is also being studied for long-term treatment of chronic ITP, as w
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