Japan becomes first nation to sanction REGEN-COV™ for COVID-19 treatment
Category: #health  By Pankaj Singh  Date: 2021-07-21
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Japan becomes first nation to sanction REGEN-COV™ for COVID-19 treatment

Regeneron Pharmaceuticals Inc. has reportedly declared that the Ministry of Health, Labor, and Welfare (MHLW) of Japan has approved the company’s imdevimab and casirivimab antibody cocktail to treat COVID-19 patients with moderate to mild symptoms.

This is the first time that the antibody cocktail Ronapreve™, or REGEN-COVTM in the United States, has obtained complete approval for treating COVID-19. Over 20 countries, including the U.S., India, Canada, Switzerland, and the European Union, have put into effect temporary or emergency pandemic use authorizations.

Dr. George D. Yancopoulos, President and Chief Scientific Officer at Regeneron, apparently commented that by implementing a rapid discovery and development program, the COVID-19 antibody cocktail has successfully reached more people across the world.

He added that continuous treatment for concerning variants of this virus is crucial as it is still spreading despite increased vaccination rates.

The antibody cocktail was awarded a Special Approval Pathway in Japan under Pharmaceuticals and Medical Devices Act’s article 14-3. The authorization was based on the results obtained from Phase 1 that observed the tolerability, pharmacokinetics, and safety in Japanese people, along with the Phase 3 trial results in high-risk patients that are non-hospitalized. It showed that the antibody cocktail curbed the risk of death or hospitalization by around 70%.

REGEN-COV was invented by Regeneron, which is partnering with Roche to increase the supply of the antibody cocktail across the world. Roche is mainly responsible for its distribution and development outside the United States.

In December 2020, Chugai got exclusive rights for development and commercialization in Japan from Roche and is collaborating with the government of Japan to assure the timely and appropriate supply of the antibody cocktail.

The manufacturing and development of REGEN-COV have been partially financed with federal funds from the BARDA (Biomedical Advanced Research and Development Authority).

For the record, REGEN-COV is a cocktail of two monoclonal antibodies, casirivimab and imdevimab, that were specially designed for blocking the infectivity of the SARS-CoV-2 virus.

Source credits:

https://www.prnewswire.com/news-releases/japan-becomes-first-country-to-approve-regeneron-antibody-cocktail-casirivimab-and-imdevimab-for-the-treatment-of-mild-to-moderate-covid-19-301336962.html



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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