Glaxosmithkline's PROMACTA Gets FDA Priority Review - Update

(RTTNews) - Pharmaceutical and healthcare company Glaxosmithkline plc (GSK | news | PowerRating | PR Charts ) said Monday that the United States Food and Drug Administration granted priority review for PROMACTA or eltrombopag, an investigational drug for the short-term treatment of patients with chronic idiopathic thrombocytopenic purpura or ITP.

ITP is a bleeding disorder caused by an abnormally low level of platelets in the patient's blood and can result in the occurrence of reddish-brown skin rashes caused by the leakage of blood from broken capillaries into the skin. People with chronic ITP often bleed from small blood vessels causing bruises, nosebleeds or even fatal gastrointestinal or intra cerebral bleeds, although these are rare, according to the company.

The priority review designation means that the FDA is expected to make a decision on the New Drug Application for the investigational compound within six months of the submission. PROMACTA is 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. In pivotal studies, the most common adverse events observed in patients taking PROMACTA were headache, nausea, nasopharyngitis, diarrhea and vomiting.

The Brentford, the United Kingdom-based GSK disclosed that it intends to submit a Marketing Authorization Application for eltrombopag in the treatment of chronic ITP in Europe in 2008. The compound is also being studied for long-term treatment of chronic ITP, as well as associated decreased number of blood platelets with Hepatitis C Virus cirrhosis and chemotherapy induced thrombocytopenia.

If approved, PROMACTA would be the first oral thrombopoeitin 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, Senior Vice President of the Oncology Medicine Development Center at GSK.

GSK closed Friday's regular trading at $43.91, down $1.14 on a volume of 2.17 million shares.

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