FDA approves Shire’s Adynovate

Shire announced that FDA has approved Adynovate, a treatment for hemophilia A, in pediatric patients under 12 years of age. The product has been approved also for use in surgical settings for both adult and pediatric patients. The approval for pediatric age was based on data from a Phase 3 trial designed to assess the immunogenicity, the safety and the efficacy of the product. (Source Shire press release)