The U.S. Food and Drug Administration (FDA) recently approved the use of NovoSeven®, the recombinant factor VIIa product manufactured by Novo Nordisk, to treat bleeding episodes in patients with acquired hemophilia.

Unlike classic hemophilia, acquired hemophilia is not an inherited condition. The onset usually occurs well into adulthood—the median age is 64--and is often associated with other conditions such as autoimmune disorders and cancer or with the use of certain drugs. Bleeding episodes in people with acquired hemophilia occur mostly in the skin and soft tissue. They are a result of the body producing antibodies that attack essential clotting factors VIII and IX, which hinder coagulation.

“The approval of NovoSeven for use in patients with acquired hemophilia offers an effective choice for treating this life-threatening disorder,” said Craig M. Kessler, MD, Chief of the Division of Hematology/Oncology, Department of Medicine, at the Georgetown University School of Medicine in Washington, DC. Kessler is incoming Chair of NHF’s Medical and Scientific Advisory Council (MASAC). “Its use will help physicians to meet the main objective in treating the disorder--stopping the bleeding episode.”

NovoSeven® is also approved by the FDA to treat bleeding episodes in people with congenital hemophilia A or B with inhibitors or factor VII deficiency.

Source: Novo Nordisk press release dated October 17, 2006