Chugai's Bispecific Antibody Hemlibra Launched in Taiwan for Hemophilia A

November 21, 2019 /BioonBIOON/ -- Chugai Pharmaceutical, a Japanese pharmaceutical company controlled by Roche, recently announced that its wholly-owned subsidiary in Taiwan has launched Hemlibra (emicizumab), a new drug for hemophilia A, to the market.

Hemlibra was approved by the Taiwan Food and Drug Administration (TFDA) in late October this year for subcutaneous administration once weekly, once every two weeks, or once every four weeks to prevent bleeding episodes in patients with hemophilia A who do not have inhibitors against coagulation factor VIII. In addition, TFDAIt also approved the Hemlibra dosing regimens of once every 2 weeks and once every 4 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. Clinical studies have demonstrated that Hemlibra significantly reduces bleeding episodes and improves 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 in the United States in November 2017FDAApproved as a routine prophylactic medication for the prevention or reduction of bleeding episode frequency in adult and pediatric patients with hemophilia A who have developed factor VIII inhibitors.

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 drugs, the development of factor VIII inhibitors, and the need for frequent intravenous infusions.

It is worth noting that Hemlibra is the first novel class of therapy approved in nearly 20 years for patients with severe hemophilia A who do not have inhibitors against factor VIII. It is also the only prophylactic treatment suitable for self-administered subcutaneous injection in patients with hemophilia A, regardless of whether they have developed inhibitors against factor VIII, offering multiple dosing regimens (once weekly, once every two weeks, or once every four weeks via subcutaneous injection).

According to Roche’s 2019 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 expected to increase significantly. Previously, Clarivate Analytics predicted that Hemlibra’s sales would reach $4 billion in 2022. (Bioon.com)

Original Source: Chugai’s Hemlibra Launched for Hemophilia A with Inhibitors in Taiwan