The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVIII] deficiency).

Acquired hemophilia A is a rare, but potentially life threatening, bleeding disorder caused by the development of antibodies (immune system proteins) directed against the body’s own FVIII, a protein important for blood clotting. When FVIII is inactivated by these autoantibodies, a person’s blood doesn’t clot normally, resulting in excessive bleeding that can occur spontaneously or following an event such as injury or surgery.

Unlike inherited hemophilia, acquired hemophilia A is not a genetic disorder and affects both males and females. The development of acquired hemophilia A has been related to other medical conditions or health states, such as pregnancy, cancer, or the use of certain medications. However, in about half of the cases, no underlying cause can be found. Diagnosis of this condition can be difficult and the severity of the bleeding can make treatment challenging.

For more details, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm420263.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery