Roche has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for its Ronapreve to treat mild to moderate Covid-19 patients.
Designed to block SARS-CoV-2 infectivity, Ronapreve is a combination of two monoclonal antibodies, casirivimab and imdevimab.
Being jointly developed by Roche and Regeneron, the antibody cocktail was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act.
The approval is based on data obtained from the Phase III REGN-COV 2067 trial performed on high-risk, non-hospitalised Covid-19 patients.
The antibody combination reduced hospitalisation or mortality risk by 70% as well as the symptom period by four days.
Additionally, the MHLW reviewed the data from a Phase I trial which examined the safety, tolerability and pharmacokinetics of Ronapreve in Japanese subjects.
Roche Global Product Development chief medical officer and head Levi Garraway said: “Ronapreve has been shown to improve survival in high-risk, non-hospitalised Covid-19 patients by reducing the risk of hospitalisation and death. In addition, its ability to retain activity against emerging variants, including the Delta variant, has been demonstrated in preclinical studies.
“Today’s approval brings hope to patients in Japan who can now access this important treatment option.”
Casirivimab and imdevimab were also found to neutralise key emerging variants of SARS-CoV-2 during the preclinical studies.
Currently, Ronapreve is authorised for emergency use or temporary pandemic use in many territories and regions, including the European Union, Switzerland, India, the US, and Canada.
In December last year, Chugai Pharmaceutical secured both development and exclusive commercialisation rights of Ronapreve in Japan from Roche.
The company is now working with the Japanese government for timely supply of the antibody cocktail.
At present, the antibody cocktail is being examined in a Phase II/III REGN-COV 2066 clinical trial to treat hospitalised Covid-19 patients.