FDA approves Baxter's hemophilia orphan drug
- Obizur (antihemophilic factor, porcine sequence) has been approved by the FDA for the treatment of acquired hemophilia A.
- Acquired hemophlia A is caused by the development of autoantibodies directed against plasma coagulation. It affects roughly 1 in 1 million people—though that figure may be higher since this condition is often diagnosed after a trauma has occurred. It affects mainly older adults between 60 and 67, though women between the ages of 20 and 30 also face increased risk during pregnancy.
- Obizur is currently under review by regulatory authorities in Canada and the EU.
Building on its long history of IV solutions and blood-collection and processing technologies dating back to the 1930's and 1940's, Baxter continues to innovate in this space.
Despite the fact that acquired hemophilia A is rare, it is extraordinarily deadly. Obizur is the first recombinant porcine FVIII treatment that is FDA-approved for the condition, and it also allows physicians to measure FVIII activity during treatment. The market for this product may be higher than expected, as the epidemiology of acquired hemophilia A is greater in the UK, where it affecta roughly 1.48 out of every 1 million people, than it is in the U.S.
- Pharma Times FDA OKs Baxter's rare haemophilia drug