Chugai Pharmaceutical's Bispecific Antibody Hemlibra Approved in Taiwan for Hemophilia A

Roche-controlled Japanese pharmaceutical company Chugai Pharmaceutical recently announced that its wholly-owned subsidiary in Taiwan has received approval from the Taiwan Food and Drug Administration (TFDA) for Hemlibra (emicizumab), a new drug for hemophilia A. The drug is administered via subcutaneous injection once weekly, every two weeks, or every four weeks for the prevention of bleeding episodes in patients with hemophilia A who do not have factor VIII inhibitors. Additionally, the TFDA has approved Hemlibra dosing regimens of once every two weeks or once every four weeks for patients with hemophilia A who have developed factor VIII inhibitors.

Hemlibra is a bispecific monoclonal antibody that brings together two proteins essential for activating the natural coagulation cascade and restoring the natural coagulation process—coagulation factors IXa and X—thereby restoring hemostasis in patients with hemophilia A. In clinical studies, Hemlibra has been demonstrated to significantly reduce bleeding events and improve physical function.

Hemlibra was developed by Chugai Pharmaceutical and is currently being co-developed by Chugai Pharmaceutical, Roche, and its subsidiary Genentech. The development of this drug aims to help overcome the clinical challenges currently faced by patients with hemophilia A: short duration of action of existing drugs, the development of factor VIII inhibitors, and the need for frequent intravenous infusions.

Hemlibra was first approved by the U.S. FDA in November 2017 as a routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed inhibitors to coagulation factor VIII.

To date, Hemlibra has been approved in more than 90 countries for patients with hemophilia A who have factor VIII inhibitors (based on the HAVEN 1 and HAVEN 2 studies), and in more than 60 countries worldwide for patients without factor VIII inhibitors (based on the HAVEN 3 and HAVEN 4 studies), to prevent or reduce the frequency of bleeding episodes. The development of this drug aims to help overcome the current clinical challenges faced by the hemophilia A community: short duration of action of existing therapies, the development of factor VIII inhibitors, and the need for frequent intravenous infusions.

Notably, Hemlibra is the first novel class of therapy approved in nearly 20 years for patients with severe hemophilia A without factor VIII inhibitors. It is also the only prophylactic treatment suitable for self-administered subcutaneous injection in patients with hemophilia A, regardless of whether they have developed factor VIII inhibitors, offering flexible dosing regimens (once weekly, once every two weeks, or once every four weeks via subcutaneous injection).

According to Roche’s 2019 annual performance report, Hemlibra achieved sales of CHF 921 million in the first nine months of the year. With the expansion of its indicated patient population and market reach, commercial sales of Hemlibra are projected to increase significantly. Previously, Clarivate Analytics predicted that Hemlibra’s sales would reach $4 billion by 2022.

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