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Chugai Pharmaceutical files to expand use of COVID-19 antibody drug

Christian Fernsby |
Chugai Pharmaceutical announced that it filed an application with the Ministry of Health, Labour and Welfare (MHLW) for approval of additional indications for the anti-SARS-CoV-2 monoclonal antibody Ronapreve for prophylaxis of COVID-19 and treatment of asymptomatic COVID-19 infected patients.

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This application also contains subcutaneous administration in addition to the drug’s current intravenous administration and seeks the Special Approval for Emergency.

This application is based on the results from the global phase III clinical study (REGN-COV 2069 study) to examine prophylaxis and treatment for asymptomatic infection, the global phase II study (REGN-COV 20145 study) to examine the dosage and dosage regimen, and the phase I clinical study (JV43180 study) to examine the safety, tolerability, and pharmacokinetics in Japanese.

REGN-COV 2069 study is a phase III, randomized, double-blind, placebo-controlled multi-part study assessing the efficacy and safety of Ronapreve in preventing symptomatic infection in household contacts of individuals infected with COVID-19.

Prevention cohort with people who had household contacts with COVID-19 patients showed that Ronapreve reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial. Treatment cohort with

recently infected asymptomatic patients showed that Ronapreve reduced risk of progressing to symptomatic COVID-19 by 31%. Adverse events (AEs) occurred in 20% (n=265 out of 1,311) of Ronapreve participants and 29% (n=379 out of 1,306) of placebo participants, and serious AEs occurred in 1% (n=10) of Ronapreve participants and 1% (n=15) of placebo participants.

The antibody cocktail combining two virus-neutralizing antibodies, casirivimab and imdevimab, is developed by U.S. 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 for the indication of SARS-CoV-2 infection with the application of the Special Approval for Emergency in July 2021.

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