Baxalta : FDA Okays Modified Antihemophilic Factor For Hemophilia A

(RTTNews) - The U.S. Food and Drug Administration approved Adynovate, Antihemophilic Factor or Recombinant, PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A. Adynovate is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding. Adynovate is manufactured by Baxalta US Inc., based in Westlake Village, California.

Adynovate is approved for on-demand (as needed) treatment and control of bleeding episodes and to reduce the frequency of bleeding episodes (prophylaxis) in patients with Hemophilia A. Adynovate consists of the full-length Coagulation Factor VIII molecule (historically known as Antihemophilic Factor) linked to other molecules, known as polyethylene glycol (PEGylated). This link makes the product last longer in the patient's blood.

ADYNOVATE will be available in the United States in the coming weeks. Baxalta continues to invest in ADYNOVATE to expand the product's value for more patients worldwide. Currently, studies are ongoing in previously treated patients (PTPs) with severe hemophilia A undergoing surgery and in pediatric PTPs under the age of 12 with severe hemophilia A. Additionally, Baxalta will initiate a study in previously-untreated patients (PUPs) with severe hemophilia A. Baxalta has filed for regulatory approval of the treatment in Japan and following completion of the pediatric study, expects to file for marketing authorization in Europe.

Hemophilia A is an inherited, sex-linked, blood-clotting disorder that primarily affects males, which is caused by defects found in the Factor VIII gene. According to the Centers for Disease Control and Prevention, Hemophilia A affects one in every 5,000 male births in the United States.