Hemophilia A treatment lasts longer in the blood and requires less frequent injections

Shire plc announced that the European Commission (EC) has granted Marketing Authorization for Adnovi [Antihemophilic 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 hemophilia A. Adnovi 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 [Antihemophilic Factor (Recombinant)], a treatment used by hemophilia A patients worldwide for almost 15 years. Adnovi’s proprietary PEGylation technology, exclusively licensed from Nektar Therapeutics, extends the time between treatments and offers a twice-weekly dosing schedule.

The Marketing Authorization is based on outcomes from three Phase III clinical trials of patients with hemophilia A. These include a prospective, global, multi-center, open label, non-randomized study of patients 12 to 65 years of age; a prospective, uncontrolled, open label, multi-center study of patients 12 years of age and younger; and a study of perioperative control of hemostasis with interim study results from 15 patients with severe hemophilia A undergoing surgical procedures.

Hemophilia A, designated an orphan disease by the EC, is a rare bleeding disorder that causes longer-than-normal bleeding due to lack of proper clotting factor VIII (FVIII) in the blood. The severity of hemophilia A is determined by the amount of factor in the blood, with more severity associated with lower amounts of factor.