FDA Approves Label Expansion for Adynovate

The FDA has approved Adynovate from Shire, an extended circulating half-life recombinant Factor VIII treatment for hemophilia A in pediatric patients younger than age 12. It also approved the product for use in surgical settings for both adults and children.

In clinical studies, the most common adverse effects associated with Adynovate were headache and nausea.

The FDA based its approval on a phase 3 trial designed to gauge the safety and efficacy of Adynovate. More than 70% of pediatric participants had zero joint bleeds while on prophylactic treatment with Adynovate. About 40% had zero bleeds.

"At Shire, we are dedicated to developing innovative therapies for patients living with hemophilia A," Philip J. Vickers, PhD, global head of research and development at Shire, said in a press release. "Today's announcement of the new FDA-approved indications for Adynovate in pediatric patients less than 12 years of age and those undergoing surgery underscores our commitment to provide treatment options with proven efficacy profiles to more patients living with hemophilia A."

Adynovate was initially approved by the FDA in November 2015. It leverages proprietary PEGylation technology from Nektar Therapeutics to extend the amount of FVIII available for use in the body. Adynovate is built on a full-length ADVATE molecule, a treatment for hemophilia A that has been used by patients for more than 13 years.