BRIEF—EU approval at last for Shire's long-acting hemophilia A therapy

The European Medicines Agency has given the green light to London-listed Shire to market its hemophilia A therapy Adynovi (antihemophilic factor, recombinant, PEGylated), marketed since 2015 in the USA as Adynovate.

The long-lasting factor VIII therapy will be indicated for on-demand and prophylactic use in patients 12 years and older.

The technology used to develop the therapy was licensed from US-based Nektar Therapeutics.

The EU regulatory submission was filed by Baxalta in early 2016, before the firm was acquired by Shire.

Hematology medical affairs head Peter Foertig said: “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 hemophilia A patients in Europe.”