UK approves rollout of 'first of its kind' Covid antibody treatment

[The King of Prussia]

Source: The Guardian

"The Medicines and Healthcare products Regulatory Agency (MHRA) said the clinical trial data they had assessed had shown Ronapreve may be used to prevent infection, treat symptoms of acute Covid-19 infection and could reduce the likelihood of being admitted to hospital because of the virus.

Trials took place before widespread vaccination and before the emergence of virus variants. It is the first monoclonal antibody combination product approved for use in the prevention and treatment of acute infection from the virus for the UK.

Monoclonal antibodies are artificial proteins that act like natural human antibodies in the immune system.

The drug, developed by Regeneron and Roche, is given either by injection or infusion and acts at the lining of the respiratory system where it binds tightly to the virus and prevents it from gaining access to the cells, the MHRA says."

Read more: https://www.theguardian.com/world/2021/aug/20/uk-approves-rollout-covid-antibody-treatment-ronapreve-clinical-trials

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Well, this sounds promising.

[LisaL]

1. It's the same drug we are already using in the US as far as I can tell.

"Ronapreve, known as REGEN-COV in the United States, can be taken via injection or infusion. It binds tightly to the coronavirus at the lining of the respiratory system and prevents it from gaining access to cells of the respiratory system, the MHRA said."

https://www.reuters.com/business/healthcare-pharmaceuticals/uk-regulator-approves-first-monoclonal-antibody-treatment-covid-19-2021-08-20/

[BumRushDaShow]

2. Yes, exactly the same

Regeneron Pharmaceuticals, Inc.

July 20, 2021 at 1:00 AM EDT

Japan Becomes First Country to Approve Regeneron Antibody Cocktail (casirivimab and imdevimab) for the Treatment of Mild to Moderate COVID-19

TARRYTOWN, N.Y., July 20, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Regeneron's casirivimab and imdevimab antibody cocktail to treat patients with mild to moderate COVID-19. This marks the first time the antibody cocktail, known as REGEN-COVTM in the U.S. and Ronapreve™ in other countries, has received a full approval to treat COVID-19. Emergency or temporary pandemic use authorizations are currently in place in more than 20 countries, including in the U.S., European Union, India, Switzerland and Canada.

https://newsroom.regeneron.com/news-releases/news-release-details/japan-becomes-first-country-approve-regeneron-antibody-cocktail

Until Regeneron/Roche gets "full approval", they can't market it with a "brand" name, although obviously they are using a place-holder name to describe it here in the U.S. while still under an EUA.

As a sidenote, Europe had been reviewing 4 other combo-cocktails -

Regeneron, GlaxoSmithKline and Eli Lilly COVID-19 drugs prioritized for expedited review in Europe

by Kevin Dunleavy | Jun 30, 2021 10:07am


Amid the global war on pandemic variants, the European Union has identified five COVID-19 therapeutics it will prioritize with the hope to authorize three by October.

Europe has selected four monoclonal antibody regimens—Eli Lilly's bamlanivimab/etesevimab combo, Celltrion’s regdanvimab, Regeneron and Roche’s casirivimab/ imdevimab cocktail and GlaxoSmithKline and Vir Biotechnology’s sotrovimab.

Also on the list is Eli Lilly’s baricitinib, a treatment already approved as Olumiant to treat rheumatoid arthritis and atopic dermatitis. The drug reduces the activity of the immune system and has been repurposed for COVID-19 patients on oxygen.

The effort is aimed at providing more regulatory flexibility with rolling reviews, conditional marketing authorizations and flexible labelling and packaging requirements. It also will allow for more scientific support from the European Medicines Agency and for the bloc to facilitate partnerships within the industry.

https://www.fiercepharma.com/pharma/covid-19-treatments-from-regeneron-lilly-gsk-vir-among-5-prioritized-for-expedited-review

[SKKY]

3. And it will for sure be much, much cheaper in the UK than here...

...because, well, 'Merica.

[The King of Prussia]

4. Well it'll be free

...because, well, socialist healthcare.