Shire: CHMP Recommends Hemophilia A Drug ADYNOVI For EU Marketing Authorization

(RTTNews) - Shire plc (SHPG, SHP.L), a biotechnology company focused on rare diseases, announced Monday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has issued a positive opinion recommending the granting of marketing authorization for ADYNOVI [Antihemophilic Factor (Recombinant), PEGylated].

The CHMP's Positive Opinion will be reviewed by the European Commission, which has the authority to grant marketing authorization in the EU.

ADYNOVI is an extended half-life recombinant Factor VIII (rFVIII) treatment, for adults and adolescents ages 12 and older living with hemophilia A for on-demand and prophylactic use.

If approved, ADYNOVI, built on ADVATE, 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 hemophilia A, a designated orphan disease by the European Commission. It is a rare bleeding disorder that causes longer-than-normal bleeding due to lack of clotting factor VIII (FVIII) in the blood.

"This positive opinion marks an important step in providing adults and adolescents with hemophilia A in Europe with the potential for a new treatment option with a twice-weekly prophylaxis dosing schedule, so patients can manage their hemophilia A care with their physicians in the way that works best for them" said Howard B. Mayer, M.D., SVP and ad-interim Head, Global Research and Development, Shire.