Posted by Michael Wonder on 28 Dec 2016
Shire announces FDA approval of Adynovate [anti-haemophilic factor (recombinant), PEGylated] for use in children and surgical settings
27 December 2016 - New FDA-approved indications for Adynovate provides more haemophilia A patients access to proven prophylaxis with a simple, twice-weekly dosing schedule.
Shire announced today that the U.S. FDA has approved Adynovate [anti-haemophilic Factor (recombinant), PEGylated], an extended circulating half-life recombinant factor VIII (rFVIII) treatment for haemophilia A, in paediatric patients under 12 years of age.
The FDA also approved Adynovate for use in surgical settings for both adult and paediatric patients. Adynovate is built on the full-length Advate [anti-haemophilic factor (recombinant)] molecule, a market leading treatment for haemophilia A with more than 13 years of real-world patient experience.
