Shire’s Adynovi has been approved for use in Europe for on-demand and prophylactic use in patients 12 years and older with the rare bleeding disorder haemophilia A.
Haemophilia A is an inherited, sex-linked, blood-clotting disorder that primarily affects males, caused by defects found in the Factor VIII gene.
Adynovi is an extended circulating half-life recombinant Factor VIII treatment designed to offer bleed protection for paediatric, adolescent and adult patients with the condition and for use during surgery.
The drug has been modified to last longer in the blood and thus potentially require less frequent injections than unmodified antihaemophilic Factor, such as the drug’s predecessor Advate, when used to reduce the frequency of bleeding.
“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 personalising disease management for haemophilia A patients in Europe,” commented Dr Peter Foertig, global head of hematology medical affairs, at Shire.
Adynovi, which Shire picked up via its multi-billion-dollar acquisition of Baxalta in 2016, is already cleared in the US under the trade name Adynovate.