Baxalta has filed its haemophilia A therapy Adynovi with regulators in Europe in the hope of offering patients a longer-acting option to reduce bleeds.
Adynovi is an extended circulating half-life recombinant Factor VIII treatment designed to bleed protection in 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.
Adynovi was recently approved in the US under the trade name Adynovate, and it is also currently being reviewed by authorities in Japan, Canada and Switzerland.
Haemophilia A is an inherited, sex-linked, blood-clotting disorder that primarily affects males, caused by defects found in the Factor VIII gene.