TOKYO, November 5, 2021
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for the anti-SARS-CoV-2 monoclonal antibody RONAPREVE® [generic name: casirivimab (genetical recombination) /imdevimab (genetical recombination)] for the additional indication of the prevention of symptomatic SARS-CoV-2 infection (COVID-19).
The Special Approval for Emergency under article 14-3 of the Pharmaceuticals and Medical Devices Act was applied to this approval. This approval allows intravenous or subcutaneous administration of Ronapreve to treat unvaccinated or inadequately vaccinated individuals who have been in close contact with COVID-19 patients or have tested positive for asymptomatic COVID-19, and are at high risk for progression to severe COVID-19. When intravenous administration is not feasible due to unavoidable circumstances, subcutaneous administration can be used for the treatment of SARS-CoV-2 infection, the indication which has been previously approved.
This approval is based on the results from the global phase III clinical study (REGN-COV 2069 study) in individuals, non-infected or infected without developing symptoms, who have been in close contact with COVID-19 patients, global phase II study (REGN-COV 20145 study) to examine the dosage and dosage regimen and a phase I clinical study to examine the safety, tolerability, and pharmacokinetics in Japanese.
Ronapreve is approved as the first antibody therapy to prevent development of symptomatic COVID-19 in individuals who have been in close contact with COVID-19 patients; and individuals who have tested positive for asymptomatic COVID-19.
The antibody cocktail combining two virus-neutralizing antibodies, casirivimab and imdevimab, is developed by U.S.-based Regeneron and Roche for the potential treatment and prevention of COVID-19. In August 2020, both companies announced a collaboration to develop, manufacture and distribute the antibody cocktail. In December of the same year, Chugai obtained development and exclusive commercialization rights in Japan from Roche. Chugai obtained regulatory approval in July 2021 for the indication of SARS-CoV-2 infection, subject to the Special Approval for Emergency.