By SPC News Staff
The FDA approved a new indication for antihemophilic factor (recombinant), PEGylated (Adynovate, Shire), an extended circulating half-life recombinant factor VIII (FVIII) treatment for hemophilia A, to treat pediatric patients younger than 12 years of age.
Adynovate will be indicated in children and adults with hemophilia A (congenital FVIII deficiency) for:
• on-demand treatment and control of bleeding episodes;
• perioperative management; and
• routine