Posted by Michael Wonder on 16 Jan 2018
Shire granted EU marketing authorisation for Adynovi [anti-haemophilic factor (recombinant), PEGylated] for adults and adolescents with haemophilia A
15 January 2018 - Marketing authorisation will enable patient access to Adynovi throughout Europe.
Shire announced today that the European Commission has granted marketing authorisation for Adynovi [anti-haemophilic factor (recombinant), PEGylated], an extended half-life recombinant factor VIII (rFVIII) treatment, 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 anti-haemophilic Factor when used to reduce the frequency of bleeding. It is built on Advate [anti-haemophilic factor (recombinant)], 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.
