PROMACTA(R) (eltrombopag) RECEIVES UNANIMOUS RECOMMENDATION BY FDA ADVI...( Panel Votes 16-0 in Favor of Shor...),Health

Panel Votes, 16-0, in Favor of Short-Term Treatment of Chronic Idiopathic Thrombocytopenic Purpura (ITP)

CHICAGO, May 30 /PRNewswire-USNewswire/ -- GlaxoSmithKline (NYSE: GSK) today announced that the United States Food and Drug Administration's Oncology Drugs Advisory Committee (ODAC) unanimously voted, 16-0, that PROMACTA(R) (eltrombopag) demonstrated a favorable risk-benefit profile for the short-term treatment of patients with chronic idiopathic thrombocytopenic purpura (ITP). The FDA advisory committee was held onsite at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting.

The advisory committee reviewed studies evaluating the safety and efficacy of eltrombopag in the short-term setting. Clinical data were presented and discussed that support eltrombopag increased platelet counts and reduced bleeding.

"Chronic ITP is a condition, which can have serious complications and be life threatening. Two of the most fundamental endpoints are crucial to managing this disease -- improved platelet counts and decreased bleeding. If approved, this would make the drug a potential new clinical option that can address a true unmet medical need," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK. "An FDA approval for eltrombopag would represent an important development for these patients and would make the medication the first oral treatment of its kind for this disease. We look forward to working with the agency to achieve that goal."

In addition to today's recommendation, the FDA recently granted eltrombopag orphan drug designation for this indication. Orphan designation is a special status the FDA grants to products that treat a rare disease or conditio
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