Chugai Pharma obtains regulatory approval for anti-SARS-CoV-2 monoclonal antibody Ronapreve
The special approval for emergency under article 14-3 of the Pharmaceuticals and Medical Devices Act was applied to this approval
Chugai Pharmaceutical has obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the anti-SARS-CoV-2 monoclonal antibody Ronapreve for Intravenous Infusion Set 300 and Set 1332 for the indication of SARS-CoV-2 infection. The special approval for emergency under article 14-3 of the Pharmaceuticals and Medical Devices Act was applied to this approval, the company said in a statement.
“The COVID-19 pandemic has entered a new phase with the emergence of multiple variants, and, in order to bring the pandemic under control as soon as possible, it is extremely important to prevent new infections with vaccines and to expand the treatment options for people with COVID-19. Ronapreve reduced the risk of hospitalisation or death, leading to suppression of aggravation and shortened time to the symptoms resolution for high-risk outpatients in a clinical study,” said Dr Osamu Okuda, President and CEO, Chugai Pharma.
He added, “Ronapreve is confirmed to be effective for the multiple variants including Delta variant in non-clinical studies. Based on this evidence, the drug received special approval for emergency, due to its urgent need to prevent the spread of diseases. We will work closely with the Japanese government and all related business partners to ensure prompt supply of the drug amid the ongoing spread of infection.”
This approval is based on the results from the global phase III clinical study (REGN-COV 2067 study) in patients with COVID-19 and a phase I clinical study to examine the safety, tolerability and pharmacokinetics in Japanese.
“Under the agreement with the Japanese government, the domestic supply of Ronapreve is secured for use in 2021. We will continue to collaborate with the Japanese government to ensure an appropriate and timely supply of the antibody cocktail,” Dr Okuda said.
Combining two virus-neutralising antibodies, casirivimab and imdevimab, Ronapreve has been created by Regeneron (US) for the potential treatment and prevention of COVID-19. In August 2020, Regeneron and Roche announced a collaboration to manufacture, develop and distribute the antibody cocktail. In December of the same year, Chugai obtained development and exclusive commercialisation rights in Japan from Roche, the statement mentioned.
It also notified that Ronapreve has not been approved in countries other than Japan at the moment.
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