Chugai gains hemophilia A indication approval for Hemlibra

Japanese drug major Chugai Pharmaceutical (TYO: 4519) has obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for the anti-coagulation factor IXa/X humanized bispecific monoclonal antibody/coagulation factor VIII substitute Hemlibra (emicizumab [genetical recombination]) for an additional indication of routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with acquired hemophilia A.

Hemlibra received orphan drug designation for this indication in October 2021, and under the priority review process, the additional indication was approved seven months after the application in November 2021, noted Chugai, which is majority-owned by Swiss pharma giant Roche (ROG: SIX).

Acquired hemophilia A is one of the immune-mediated acquired coagulation factor deficiencies listed among the designated intractable diseases in Japan (designated intractable disease 288). The disease is associated with repeated episodes of sudden hemorrhage due to the development of inhibitors (autoantibodies) against blood coagulation factor VIII.