BeneFIX, Coagulation Factor IX (Recombinant)
Company: Genetics Institute
Approval Status: Recommended for approval December 1996
Treatment for: hemophilia B
Areas: Hematology
| General Information | Additional Information |
General Information
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.
Additional Information
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).
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
