The MHLW approval is based on a global Phase 3 trial which found Ronapreve reduced 70% hospitalisation or death in high-risk patients
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve (casirivimab and imdevimab), developed by Roche and Regeneron, to treat patients with mild to moderate Covid-19.
Ronapreve is a combination of two monoclonal antibodies REGN10933 and REGN10987 to block the infectivity of SARS-CoV-2.
The antibody combination has received a Special Approval Pathway under Japan’s Pharmaceuticals and Medical Devices Act.
Also, it has been authorised for emergency use in additional territories and regions outside Japan, including in the EU, the US, India, Switzerland and Canada.
Roche chief medical officer and global product development 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.”
The MHLW approval is based on results from the global Phase 3 REGN-COV 2067 study in high-risk non-hospitalised patients with Covid-19.
Also, the approval was based on Phase 1 clinical study, examining the safety, tolerability and pharmacokinetics of the combination in Japanese people.
The Phase 3 study results showed that casirivimab and imdevimab reduced hospitalisation or death by 70% and symptom duration by four days.
Ronapreve is currently under rolling review by the European Medicines Agency (EMA) and was granted the Committee for Medicinal Products for Human Use (CHMP) opinion.
It will serve as a treatment option for Covid-19 patients who do not require oxygen supplementation and are at high risk of progressing to severe Covid-19, said Roche.
Earlier this month, Regeneron announced around $1.8bn investment to expand its research, preclinical manufacturing and support facilities in Westchester County, New York City.