Shire Plc Announces New FDA-approved Indications For ADYNOVATE - Quick Facts

(RTTNews) - Shire plc (SHPG, SHP.L) announced the U.S. FDA has approved ADYNOVATE, 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 for use in surgical settings for both adult and pediatric patients.

ADYNOVATE was first approved by the FDA in November 2015. The approval of ADYNOVATE to treat children under the age of 12 was based on data from a prospective, uncontrolled, open-label, multi-center Phase 3 trial designed to assess the immunogenicity along with the safety and efficacy of ADYNOVATE.