CHMP has recommended EU marketing authorisation for Adynovi, Shire’s treatment for adults and adolescents with Haemophilia A.
Adynovi is an extended half-life recombinant Factor VIII treatment, for adults and adolescents ages 12 and older living with haemophilia A for on-demand and prophylactic use.
If approved, it would offer twice-weekly prophylactic dosing as well as on-demand control of bleeding episodes.
The CHMP submission was based on outcomes from three Phase 3 clinical trials of patients with haemophilia A.
CHMP’s Positive Opinion will be reviewed by the European Commission, which has the authority to grant marketing authorization in the EU.