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Platelet Treatment Wins FDA Panel's Support
Thursday, 13 March 2008
In a  federal panel meeting  a propose of  Amgen Inc. drug to treat a rare blood-platelet illness, and sales restrictions would be included out of concern that the drug might contribute to other serious blood disorders.

The drug would be sold under the proposed brand name Nplate to treat immune thrombocytopenic purpura, or ITP, an autoimmune bleeding disorder marked by below-normal levels of platelets. Platelets help form clots to stop bleeding, and Nplate is designed to increase platelet levels in a different manner than other treatments. If approved, the product would likely be injected weekly in a doctor's office.

The Food and Drug Administration panel unanimously said Nplate had a favorable risk-benefit profile; its vote amounts to a recommendation that the FDA approve the drug. The agency usually follows its panels' advice.