Baxalta Announces U.S. Availability Of Adynovate - Quick Facts

(RTTNews) - Baxalta Inc. (BXLT) announced the launch and first shipments of Adynovate [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on full-length ADVATE [Antihemophilic Factor (Recombinant)]. The treatment was approved by the U.S. Food and Drug Administration in November.

The company noted that it continues to invest in Adynovate to expand the product's value for more hemophilia patients worldwide.

As the company prepares for additional global introductions of Adynovate, the treatment has been submitted for regulatory approval in Japan. Following completion of the pediatric study in early 2016, Baxalta said it expects to file for marketing authorization in Europe.