Chugai files for COVID-19 antibody cocktail approval in Japan

Japanese drug major Chugai Pharmaceutical (TYO: 4519) has filed a new drug application with the Ministry of Health, Labor and Welfare (MHLW) for the antibody cocktail casirivimab and imdevimab (formerly known as REGN-COV2) for the treatment of COVID-19. The application seeks the Special Approval for Emergency.

Last month, Chugai reached agreement with the Japanese government to secure the antibody cocktail for the year 2021 for domestic supply, if it is approved by the regulatory authority in Japan.

“The COVID-19 pandemic, including the spread of infections of variants, has been persistent, and new treatment options are needed. The antibody cocktail casirivimab and imdevimab significantly reduced the risk of hospitalization or death in high-risk, non-hospitalized patients with COVID-19 in a global phase III clinical study,” said Chugai’s president and chief executive Dr Osamu Okuda. “We will collaborate closely with Japanese health authority to deliver this antibody cocktail as a new treatment to patients as soon as possible.”