Shire can market in EU Adynovi for certain hemophilia A patients

The European Commission (EC) has given Shire’s ADYNOVI a green light as an extended half-life recombinant factor VIII (rFVIII) treatment for certain hemophilia A patients.

According to the company’s press release, the authorisation is given for on-demand and prophylactic use in patients 12 years and older.

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 hemophilia 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 hemophilia A. 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,” said Dr. Peter Foertig, Global Head Hematology Medical Affairs, Shire.

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.7 More than half of patients with hemophilia A have the severe form of the condition. Today, hemophilia A affects approximately 150,000 across the globe.8 It primarily affects males, with an incidence of one in 5,000 male births. Of the worldwide hemophilia patient population, an estimated 75 percent lack adequate treatment or access to treatment altogether.