Shire will now be able to use its Adynovate for treating heamophilia A in children younger than 12 years of age, as the the U.S. Food and Drug Administration (FDA) has approved it for that age group.
The FDA also approved it for use in surgical settings for both adult and children patients. Adynovate is built on the full-length Advate, Antihemophilic Factor (Recombinant) molecule, a market leading treatment for haemophilia A with more than 13 years of real-world patient experience.
Llead investigator Eric Mullins, M.D., Research Director, Hemophilia Treatment Center in Cincinnati said that this is good news for more haemophilia patients. “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 said.
“At Shire, we are dedicated to developing innovative therapies for patients living with hemophilia A,” said Philip J. Vickers, Ph.D., Global Head of Research and Development at Shire. “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.”
This drug was first approved by the FDA in November 2015.