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GlaxoSmithKline Receives FDA Approval For PROMACTA

GlaxoSmithKline plc (GSK) Monday said the U.S. Food and Drug Administration has approved PROMACTA for the treatment of low blood platelet counts in patients with chronic hepatitis C.

PROMACTA is the first supportive care treatment available to patients who are ineligible for interferon-based therapy due to their low blood platelet counts.

The approval for PROMACTA was based on results from ENABLE 1 and 2, a two Phase III randomized, double-blind, placebo-controlled, multicenter studies, which collectively enrolled 1,521 patients with lower platelet counts.

"Some chronic hepatitis C patients suffer from low blood platelet counts. Commonly prescribed interferon-based therapies can worsen the problem of low blood platelet counts. Today's FDA approval of PROMACTA gives doctors a tool to address the low platelet challenge, " said Paolo Paoletti, M.D., President, GlaxoSmithKline Oncology.

by RTT Staff Writer

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