BeneFIX (coagulation Factor IX (recombinant))Company: Genetics Institute
Approval Status: Recommended for approval December 1996
Treatment for: hemophilia B
Possible similar drugs: BeneFIX
BeneFIX, Coagulation Factor IX (Recombinant) has been approved as the first recombinant blood clotting therapy for hemophilia B. BeneFIX eliminates the risk of transmitting blood- borne viruses such as hepatitis which have been associated with Factor IX therapies made from human plasma.
As a result of viral contamination from earlier plasma-derived clotting therapies, over 20% of U.S. hemophilia patients are HIV positive and over 70% have hepatitis. Since BeneFIX is made through recombinant technology, without the addition of blood or plasma products, it eliminates the risk of potential blood-borne viral contamination. Further, the supply of BeneFIX does not depend on blood donors.
An inherited disorder that almost exclusively affects males, hemophilia B is caused by a deficiency or defect in Factor IX, one of a number of proteins involved in blood clotting. Factor IX deficiency results in frequent hemorrhages that can be crippling and, at times, life-threatening. The disorder affects about 7,000 people in North America, Europe and Japan (approximately 3,000 patients in the United States).
BeneFIX Drug Information
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