Baxalta gains approval for Adynovate in USA and for Obizur in EU

US biotech firm Baxalta (NYSE: BXLT) said on Friday that the US Food and Drug Administration has approved Adynovate [antihemophilic Factor (recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A.

Adynovate is built on the full-length Advate [antihemophilic Factor (recombinant)] molecule, a leading treatment for hemophilia A with more than 12 years of real-world patient experience. Advate is the world's most prescribed hemophilia treatment, according to the company, whose shares edged up 1.6% to $33.79 by close of trading on Friday.

Adynovate will be available in the USA 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.