AHA is a very rare and potentially life-threatening acute bleeding disorder that typically affects older adults and occurs in both males and females.
Obizur, which contains a recombinant analogue of porcine FVIII, allows physicians to manage the treatment’s efficacy and safety by measuring factor VIII activity levels in addition to clinical evaluations.
The approval is based on a global, prospective, controlled, multi-center Phase II/III open-label clinical trial that evaluated the efficacy of Obizur in the treatment of serious bleeding episodes in 29 adults with AHA.
Baxter hemophilia franchise head Brian Goff said: "As a new treatment option with the ability to measure FVIII activity in the body, Obizur will address important unmet needs for patients with acquired hemophilia A, a potentially life-threatening condition.
"This approval reflects Baxter’s long-standing commitment to discovering new options for hemophilia patients and adds to our portfolio of treatments that reduce the burden of these diseases."
The company said that Obizur will be launched in the US soon and is currently under regulatory review in Europe and Canada.