Shire has picked up European Marketing Authorisation for Adynovi for on-demand and prophylactic use in patients 12 years and older living with haemophilia A.
Adynovi is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding.
It is built on Advate, a treatment used by haemophilia A patients worldwide for almost 15 years.
Adynovi’s proprietary PEGylation technology, exclusively licensed from Nektar Therapeutics, extends the time between treatments and offers a twice-weekly dosing schedule.
“The European approval of Adynovi is an important milestone in our continued commitment to provide new treatment options for patients living with haemophilia A,” said Peter Foertig, Global Head Hematology Medical Affairs, Shire.
“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 personalizing disease management for haemophilia A patients in Europe.”
The Marketing Authorization is based on outcomes from three Phase 3 clinical trials of patients with haemophilia A.
With this approval, Shire is now authorized to market Adynovi in the 28 Member States of the European Union, as well as in Iceland, Liechtenstein and Norway.