Japan Approves COVID-19 Antibody Cocktail Treatment
New York-based Regeneron Pharmaceuticals, Inc. announced that Japan's Ministry of Health, Labour, and Welfare approved Regeneron's REGEN-COV casirivimab and imdevimab antibody cocktail to treat patients with mild to moderate COVID-19.
This marks the first time the antibody cocktail, known as Ronapreve™ in other countries, has received full approval to treat COVID-19.
Emergency or temporary pandemic use authorizations are currently in place in more than 20 countries.
In Japan, the approval was based on results from a Phase 3 trial in high-risk non-hospitalized patients, which showed the antibody cocktail reduced the risk of hospitalization or death by 70%, as well as results from a Phase 1 trial that examined the safety, tolerability, and pharmacokinetics in Japanese people.
In the U.S., REGEN-COV can be administered by intravenous infusion (as short as 20 minutes) or by subcutaneous injection (4 injections), which is an alternative when the intravenous infusion is not feasible and would lead to a delay in treatment. In addition, it is now authorized as a co-formulated single vial or in individual vials to be administered together.
"After a record-speed discovery and development program, we are pleased that our COVID-19 antibody cocktail continues to reach even more people around the globe," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron, in a press release.
"Unfortunately, this virus continues to spread despite increasing rates of vaccination, and there will be an important continued need for treatments that remain active against the variants of concern."
Regeneron invented REGEN-COV and is collaborating with Roche to increase the global supply of the antibody cocktail, with Roche primarily responsible for development and distribution outside the USA.
In December 2020, Chugai obtained development and exclusive commercialization rights in Japan from Roche and worked with the Japanese government to ensure an appropriate and timely supply of the antibody cocktail.
The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority.
Regeneron (NASDAQ: REGN) is a physician-scientists-led biotechnology company that invents life-transforming medicines for people with serious diseases.