Chugai Pharmaceutical Co., Ltd. has launched its anti-coagulation factor IXa/X humanized bispecific monoclonal antibody/coagulation factor VIII substitute, (brand name, “Hemlibra subcutaneous injection 30 mg, 60 mg, 90 mg, 105 mg, 150 mg for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with congenital factor VIII deficiency (haemophilia A) with factor VIII inhibitors.
Hemlibra received a manufacturing and marketing approval on March 23, 2018 and was listed on the National Health Insurance (NHI) reimbursement price list.
Congenital haemophilia A is a disorder where a person’s blood does not clot properly due to congenital missing or defective factor VIII, leading to serious bleeding symptoms that occur repeatedly. In Japan, it is reported that about 5,000 people have congenital haemophilia A). The current standard treatment for haemophilia A is factor VIII replacement therapy, however, 25-30% of people with severe congenital hemophilia A develop inhibitors (neutralizing antibodies) that reduce the effects of treatment).
“We are pleased that Hemlibra, which was created with Chugai’s proprietary bispecific antibody technologies, is now available as a new approach to the treatment of haemophilia A in Japan following the U.S. and Europe,” said Chugai’s President & CEO, Tatsuro Kosaka. “Once people with haemophilia A develop inhibitors against the standard treatment, treatment options become limited, and one of the issues encountered in the treatment was that this may lead to the exacerbation of the disorder. Hemlibra is a drug with a novel mode of action that prevents or reduces the frequency of bleeding episodes with once-weekly subcutaneous injection. We believe that the drug will make a significant contribution to people with haemophilia A with inhibitors both in terms of preventing or reducing bleeding episodes and improving their quality of life.”
Hemlibra is a bispecific antibody, which was created with Chugai’s proprietary antibody engineering technologies. The drug binds to activated factor IX and factor X, providing the cofactor function of factor VIII in people with haemophilia A, who either lack or have impaired function of factor VIII). Through once-weekly subcutaneous injection, which can be self-administered, Hemlibra is expected as an antibody drug which can prevent or reduce the frequency of bleeding episodes in people with haemophilia A with inhibitors. The drug was filed for approval for the treatment of haemophilia A without inhibitors in April 2018.