BRIEF—Chugai files for Japanese approval of additional indication for Hemlibra

Chugai Pharmaceutical, which is majority-owned by Swiss pharma giant Roche, has filed an application for expanded use of its anti-coagulation factor IXa/X humanized bispecific monoclonal antibody/coagulation factor VIII substitute, Hemlibra (emicizumab) subcutaneous injection.

The submission to the Ministry of Health, Labor and Welfare (MHLW) is for an additional indication of prophylactic treatment for people with hemophilia A without inhibitors to factor VIII, as well as for additional dosage and administration as a biweekly or every four-week treatment for people with haemophilia A with inhibitors to factor VIII.

“Hemlibra has recently been designated as a Breakthrough Therapy from the US Food and Drug Administration (FDA) for the treatment of hemophilia A without inhibitors to factor VIII. We are very glad that the filing to include this indication has been successfully submitted in Japan,” said Chugai’s executive vice president, co-head of project and lifecycle management unit, Dr Yasushi Ito.

“The purpose of the two filings is to obtain approval for weekly, biweekly, and every four-week subcutaneous injections of Hemlibra regardless of the presence of inhibitors to factor VIII. Chugai is committed to seek approval so that we may deliver Hemlibra to people with haemophilia A without inhibitors as a new therapeutic option, as well as to further improve convenience for people with inhibitors by extending the dosing interval as soon as possible,” he added.