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A Food and Drug Administration panel voted unanimously today that Amgen Inc.’ Nplate drug, used to treat a rare blood clotting disorder, provides enough benefit to counteract the side effects associated with its use.
Nplate is intended to treat Idiopathic Thrombocytopenic Purpura (ITP), an autoimmune disorder characterized by very low levels of platelets leading to uncontrolled bleeding. Platelets are involved in clotting and are needed to stop bleeding, and Nplate is designed to boost levels in a different manner than other treatment.
Amgen’s drug would treat chronic forms of ITP. To support the drug, Amgen submitted the results of two main clinical studies involving patients with ITP who failed other treatments. The FDA said the studies showed most patients treated with Nplate had an improvement in blood-platelet levels.
According to the medical officer reviewing Nplate, the product was a “safe and effective alternative in raising the platelet count to levels where patients are no longer considered to be at increased risk for serious bleeding.”
However, the FDA also noted that 14 of 204 patients treated with NPLATE had dangerous blood clots. In addition, 8 percent of patients taking NPLATE developed a resistance to the drug, while only 4 percent of patients taking placebo showed the similar results. The FDA also expressed concerns about abnormal marrow growth and malignant tumors seen in some patients.
ITP, which causes bruising and bleeding after minor injuries, affects about 200,000 people in the U.S., according to the Platelet Disorder Support Association.
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