FDA Approved Drugs » 1997
Medical Areas: Hematology | Genetic Disease

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BeneFIX (coagulation Factor IX (recombinant))

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Genetics Institute
Approval Status: Approved February 1997
Treatment Area: hemophilia B

General Information

BENEFIX, Coagulation Factor IX (Recombinant), has been approved as the first recombinant blood clotting therapy for the treatment of Hemophilia B. BENEFIX, which is made through recombinant DNA technology, is inherently free from the risk of transmitting blood-borne viruses such as hepatitis, which has been associated in the past with Factor IX products made from human plasma. Over 20% of U.S. hemophilia patients are HIV positive, and over 70% have hepatitis because of contamination from plasma-derived clotting therapies.

Additional Information

Hemophilia B is caused by a deficiency or defect in Factor IX, one of a number of factors involved in blood clotting. It is an inherited disorder that primarily affects males. Factor IX deficiency results in frequent hemorrhages that can be crippling and life-threatening. The disorder affects 7,000 people in North America, Europe and Japan (approximately 3,300 in the U.S.).