Hemophilia A drug Adynovate approved for new indications by FDA

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, in pediatric patients under 12 years of age.

The FDA also approved Adynovate, from Ireland-headquartered Shire (LSE: SHP), for use in surgical settings for both adult and pediatric patients. Adynovate is built on the full-length ADVATE (antihemophilic Factor [recombinant]) molecule, a market leading treatment for hemophilia A with more than 13 years of real-world patient experience.

“Physicians need additional treatment options for pediatric patients and those undergoing surgery with hemophilia A,” said lead investigator Eric Mullins, research director, Hemophilia Treatment Center, Cincinnati Children’s Hospital Medical Center. “As someone who has routinely seen the benefits of factor replacement in adult patients with hemophilia A, I am pleased to be able to provide Adynovate to more patients,” he added.