Genetics Institute's Factor IX Approved In 1st Market

American Home Products' biotechnology subsidiary, Genetics Institute,has been granted US Food and Drug Administration approval for Benefix (recombinant Factor IX), a clotting factor used to treat hemophilia B. As the Marketletter was going to press (February 13), GI said it was aiming to launch the product onto the market within 48 hours.

Hemophilia B affects around 10,000 people worldwide. It represents about 15% of all hemophilia cases. Current management of the disease with plasma-derived factors is effective, but a recombinant form offers clear advantages. Despite the small number of patients involved, blood-derived Factor IX therapies constitute a market of around $150 million. Benefix has Orphan Drug designation in the USA.

There has been considerable expectation in the hemophilia B community for Benefix. Since the advent of recombinant Factor VIII for the treatment of hemophilia A, the hemophilia B patient population has been anxiously awaiting the availability of a similar treatment, which is inherently free from the risk of blood-borne pathogens such as HIV, hepatitis viruses and parvovirus.