Policy & Regulation
Shire receives marketing authorisation from the European Commission for Adynovi
18 January 2018 -

Ireland-based Shire has received marketing authorisation from the European Commission for its Adynovi [Antihaemophilic 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, it was reported yesterday.

The product is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihaemophilic Factor when used to decrease the frequency of bleeding. It is based on ADVATE [Antihaemophilic Factor (Recombinant)], a treatment used by haemophilia A patients globally for almost 15 years.

The marketing authorisation is based on results from three Phase three clinical trials of patients with haemophilia A. These include a prospective, global, multi-centre, open label, non-randomised study of patients 12 to 65 years of age; a prospective, uncontrolled, open label, multi-centre study of patients 12 years of age and younger; and a study of perioperative control of haemostasis with interim study results from 15 patients with severe haemophilia A undergoing surgical procedures.

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