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FDA clears Amgen drug for blood disorder

August 23, 2008|From the Associated Press

WASHINGTON — Federal regulators Friday approved a biotech drug from Amgen Inc. to treat a rare blood clotting disorder.

The Food and Drug Administration approved Nplate for patients with a disorder that causes the body to attack its own platelets, which are tiny components of blood that help with clotting.

The condition called thrombocytopenia can cause bruising and bleeding after minor injuries. According to Thousand Oaks-based Amgen, it affects an estimated 60,000 adult patients in the U.S.

Nplate is the first drug that directly encourages platelet production by stimulating the patient's bone marrow, regulators said.

The FDA approved the drug based on two studies that showed it increased patients' platelet count over six months.

But regulators said they would require all patients who receive Nplate to enroll in a long-term safety study because of risks associated with it.

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