Chugai files for new indication for Hemlibra in hemophilia A

Japanese pharma major Chugai Pharmaceutical (TYO: 4519) says it has filed an application with the Ministry of Health, Labor and Welfare (MHLW) for approval of additional indication for the anti-coagulation factor IXa/X humanized bispecific monoclonal antibody/coagulation factor VIII substitute Hemlibra (emicizumab [genetical recombination]) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in people with acquired blood coagulation factor VIII deficiency.

In October 2021, Hemlibra received orphan drug designation from the MHLW for this setting, and the application is subject to priority review, said Chugai, which is majority owned by Swiss pharma giant Roche (ROG: SIX).

“Acquired hemophilia A is a disease with high unmet medical needs and designated as an intractable disease in Japan. More treatment options are needed for this disease, and I am glad that we have filed application for Hemlibra for this indication,” said Dr Osamu Okuda, Chugai’s president and chief executive, adding: “Since its launch in 2018, Hemlibra has been used widely as a treatment option for congenital hemophilia A in children and adults. Chugai will continue working toward obtaining approval to contribute to the treatment of acquired hemophilia A.”