BRIEF—Chugai's Hemlibra approved in Taiwan

The local subsidiary of Japan’s Chugai has obtained approval from the Taiwan Food and Drug Administration (TFDA) for its bispecific monoclonal antibody Hemlibra (emicizumab-kxwh) for routine prophylaxis of bleeding episodes in patients with hemophilia A with factor VIII inhibitors by once weekly subcutaneous injection.

“We are pleased that HEMLIBRA has received regulatory approval for hemophilia A with factor VIII inhibitors now in Taiwan,” said Dr Yasushi Ito, executive vice president, co-head of project and lifecycle management unit, of Chugai, which is majority-owned by Swiss pharma giant Roche.

He continued: “Chugai will cooperate with Chugai Pharma Taiwan so that Hemlibra may contribute to people with hemophilia A with inhibitors who have limited treatment options.”

This approval is based on data from two pivotal studies in people with hemophilia A with factor VIII inhibitors: results of HAVEN 1 study (NCT02622321) in adolescents and adults, and the interim analysis of HAVEN 2 study (NCT02795767) in children.