ADYNOVI is an extended half-life recombinant factor VIII (rFVIII) treatment indicated for on-demand and prophylactic use in haemophilia A patients aged 12 and above.
Based on the Antihaemophilic Factor (Recombinant) (ADVATE) treatment, the drug has been modified to ensure longer retention in blood and potentially less frequent injections when used to minimise the bleeding frequency, compared to unmodified Antihaemophilic Factor.
ADYNOVI employs PEGylation technology, which is exclusively licensed from Nektar Therapeutics, to extend the time between treatments, providing twice-a-week dosing schedule.
Shire Haematology Medical Affairs global head Dr Peter Foertig said: “The European approval of ADYNOVI is an important milestone in our continued commitment to provide new treatment options for patients living with haemophilia A.
“We believe that the twice-weekly prophylactic dosing, as well as the on-demand control of bleeding, offered by ADYNOVI will bring us closer to our goal of improving and personalising disease management for haemophilia A patients in Europe.”
The EC authorisation is based on the findings from a prospective, global, multi-centre, open label, non-randomised Phase III clinical trial of subjects aged 12 to 65.
In addition, the commission also reviewed outcomes from another Phase III prospective, uncontrolled, open-label, multi-centre trial with participants aged 12 and below, and a perioperative control of haemostasis study in 15 severe haemophilia A patients receiving surgical procedures.