HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Sunday, August 24, 2008

Drug to Help Blood Clot Is Approved

The New York Times reports that the Food and Drug Administration approved Nplate for patients with a disorder that causes the body to attack its own platelets.  The New York Times writes,

Amgen_logoOn Friday, federal regulators approved a biotechnology drug from Amgen that treats a rare blood-clotting disorder.

The Food and Drug Administration approved the drug, Nplate, for patients with a disorder that causes the body to attack its own platelets, tiny components of blood that help with clotting. The condition, which can cause bruising and bleeding after minor injuries, affects about 140,000 people.

Regulators said Nplate is the first drug that directly encourages platelet production by stimulating the patient’s bone marrow.

The F.D.A. approved the drug based on two studies that showed that it increased patients’ platelet count over six months. Patients received weekly injections of Nplate, a genetically engineered version of the protein that encourages platelet production.

“The Nplate approval is the result of 15 years of research into understanding how platelets are produced in the bone marrow,” Amgen, based in Thousand Oaks, Calif., said.

Regulators said they would require all patients who receive the drug to enroll in a long-term safety study because of some risks associated with it.

During its review of the drug, the F.D.A. questioned its potential to cause bone-marrow abnormalities and dangerous blood clots. In addition, four patients in studies of the drug developed leukemia.

The F.D.A. said in its announcement that more studies “will be needed to determine whether the development of leukemia may relate to the use of Nplate.”

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