Cocktail COVID-19 Neutralizing Antibody was Officially Approved in Japan to Build a Second Line of Defense

Recently, Ronapreve, a product of Roche Pharmaceuticals, was approved by the Japanese Ministry of Health, Labour and Welfare for the treatment of mild to moderate COVID-19 patients by intravenous infusion. 

Ronapreve is a cocktail COVID-19 neutralizing antibody therapy jointly developed by Roche and Regeneron. It is composed of Casirivimab and Imdevimab, which is aimed at two independent and non-overlapping sites in the receptor binding region of SARS-CoV-2 spike protein (S protein). It has synergistic effect, which can reduce the risk of virus mutation and escape and protect people from virus variants with mutation of s protein. 

First COVID-19 neutralizing antibody officially approved for marketing in the world 

According to Article 14-3 of the Law on Drugs and Medical Devices, this cocktail antibody combination therapy has obtained special approval from Japanese Ministry of Health, Labor and Welfare. This therapy is the first neutralizing antibody for treating mild to moderate COVID-19 patients in the world. Ronapreve has been shown to improve the survival rate of high-risk, non-hospitalized COVID-19 patients by reducing the risk of hospitalization and death. 

The approval of Ronapreve by the Japanese Ministry of Health, Labour and Welfare is mainly based on the results of a Phase III clinical study named REGN-COV 2067. REGN-COV 2067 is a randomized, double-blind, placebo-controlled phase III clinical trial. The evaluation results of 4567 high-risk COVID-19 outpatients show that: compared with placebo, REGN-COV2067 can reduce hospitalization or death by 70%, reduce symptom duration by 4 days, and significantly reduce viral load within 7 days of treatment. 

In addition to the REGN-COV 2067 clinical trial for COVID-19 patients, Ronapreve is currently being evaluated in a Phase II/III clinical trial (REGN-COV 2066), which aims to evaluate the therapeutic effect of COVID-19 patients in hospital. 

Second line of defense 

At present, the cumulative number of confirmed cases in COVID-19 has exceeded 190 million, and the cumulative number of deaths in COVID-19 is nearly 4.1 million. As some regions worldwide have lifted bans for pandemic prevention since July, people has contacted frequently and the virus continued to mutate. For many reasons, a new round of pandemic can be seen in many areas around the world. Get latest infomation about api ingredients on Pharmasources.

The cumulative number of people who have been vaccinated against COVID-19 has exceeded one billion times. With the widespread vaccination of the COVID-19 vaccine, we are building the first line of defense for the prevention and protection of COVID-19. However, SARS-CoV-2 is still mutating. With the popularization and vaccine of available vaccines and the vaccine against the variants to be developed in the future, it may become popular for people to be vaccinated in the next few years. 

At this crucial moment for global economic recovery and the restart of life order, all countries are faced with the urgent need to fight against pandemic and restore social life order. It is not enough to build the first line of defense of prevention and protection only by vaccination of COVID-19 vaccine. It is necessary to take effective COVID-19 neutralizing antibody therapy in time for the confirmed infected people of SARS-CoV-2. This COVID-19 neutralizing antibody therapy has built the second line of defense for the current human treatment and protection. 

The scope of use is expanding. 

It is worth noting that besides the official approval of the Japanese Ministry of Health, Labour and Welfare, Casirivimab and Imdevimab cocktail therapies have been authorized for emergency use or temporary use for pandemic in many countries and regions including the European Union, the United States, India, Switzerland and Canada. With the review of local drug regulatory agencies, this cocktail therapy will be officially approved in more countries in the future. 

The European Medicines Agency (EMA) of the European Union is conducting a rolling review of Casirivimab and Imdevimab cocktail therapy, and the Committee for Medicinal Products for Human Use (CHMP) has issued positive scientific opinions, supporting this cocktail therapy as a treatment option for patients who have been diagnosed with COVID-19, do not need oxygen supplementation, and have a high risk of developing into severe COVID-19. 

In the United States, Casirivimab and Imdevimab cocktail therapy are granted with Emergency Use Authorization (EUA), which is used to treat mild to moderate COVID-19 children and adult patients who are positive for direct SARS-CoV-2 virus test, at high risk of developing into severe COVID-19 and/or hospitalized, aged ≥12 years and weighing ≥40kg. 

About  the Author:    

Xiaoyaowan, a pharmaceutical industry practitioner, a word carrier in the We-media era focusing on changes of the pharma industry.