Baxalta Incorporated announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval of ADYNOVI, an extended circulating half-life recombinant Factor VIII (rFVIII) treatment, for pediatric, adolescent and adult patients with hemophilia A and for use during surgery. Currently licensed in the U.S. as ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] and under regulatory review in Japan, Canada and Switzerland, ADYNOVI is the only rFVIII treatment for hemophilia A developed based on the demonstrated efficacy of ADVATE [Antihemophilic Factor (Recombinant)].
ADYNOVI was studied in patients, 12 to 65 years of age, 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.
