Baxalta Submits MAA To European Medicines Agency For Adynovi- Quick Facts

(RTTNews) - Baxalta Inc. (BXLT), said it has submitted a Marketing Authorization Application or MAA to the European Medicines Agency (EMA) for approval of Adynovi, an extended circulating half-life recombinant Factor VIII treatment, for pediatric, adolescent and adult patients with hemophilia A and for use during surgery.

Currently licensed in the U.S. as Adynovate and under regulatory review in Japan, Canada and Switzerland, Adynovi is the only recombinant Factor VIII or rFVIII treatment for hemophilia A developed based on the demonstrated efficacy of Advate [Antihemophilic Factor (Recombinant)].

Adynovi was studied in patients, aged 12 to 65 years, in a prospective, global, multi-center, open label, non-randomized study; in patients 12 years of age and younger, in a prospective, uncontrolled, open-label, multi-center study; and for the perioperative control of hemostasis among 15 patients with severe hemophilia A undergoing surgical procedures.

The EMA filing is based on data from these three Phase 3 clinical trials, which Baxalta shared publicly in December 2015.

Hemophilia A is a challenging chronic disease; treatment regimens require regular infusions to reduce the risk of bleeding. Today, hemophilia affects more than 400,000 people globally and an estimated 75 percent of people with hemophilia are inadequately treated.