FDA approves Adynovate for children, surgical settings
“Physicians need additional treatment options for pediatric patients and those undergoing surgery with hemophilia A,” Dr. Eric Mullins, the research director of the Hemophilia Treatment Center at Cincinnati Children’s Hospital Medical Center, said. “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.”
Adynovate was approved after a prospective, uncontrolled, open-label, multi-center Phase 3 trial to assess the immunogenicity, safety and efficacy of Adynovate. In the trial, no treatment-related serious adverse events were reported in the children while more than 70 percent of children had no joint bleeds and almost 40 percent experienced zero bleeds.
“At Shire, we are dedicated to developing innovative therapies for patients living with hemophilia A,” Global Head of Research and Development Philip Vickers said. “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.”
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