(RxWiki News) The US Food and Drug Administration (FDA) approved a new treatment Thursday for a rare form of hemophilia.
The new treatment proved safe and effective in a clinical trial, the FDA reports.
Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] was approved to treat bleeding episodes in adults with acquired hemophilia A.
“The approval of this product provides an important therapeutic option for use in the care of patients with this rare disease,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release.
Acquired hemophilia A is a rare but deadly bleeding disorder. In patients with the disorder, the blood won't clot correctly, which can lead to excessive bleeding. Blood will not clot in these patients because their bodies produce an antibody (immune response) that fights a protein that aids in blood clotting.
Obizur fights acquired hemophilia A with another protein that can make blood clot. That protein is similar to the one patients' bodies attack, but not similar enough for the body to attack it, too, the FDA reports.
The new treatment was tested in a trial of 29 adults with acquired hemophilia A. The patients received Obizur to treat bleeding episodes. The treatment proved effective.
The FDA reports that the trial found no safety concerns for Obizur.
Obizur is produced by Baxter Healthcare in Westlake Village, CA.
