Health

Regeneron to ask FDA to use its COVID-19 antibody drug as a preventative treatment


Regeneron Pharmaceuticals plans to ask the U.S. Food and Drug Administration (FDA) to allow its COVID-19 monoclonal antibody cocktail to be used as a preventative treatment. 

It comes after data from a Phase III clinical trial, run together with the National Institutes of Health, found the drug reduced the risk of asymptomatic coronavirus  patients developing symptoms by 76 percent on the third day.

The treatment is a mixture of drugs casirivimab and imdevimab, and was developed by the New York City-based company in partnership with pharmaceutical firm Roche.

Known as REGEN-COV, the cocktail imitates antibodies that the body generates when fighting the virus in order to boost the immune system.  

The cocktail was given to former President Donald Trump when he was infected with COVID-19 in October 2020, and which he hailed as ‘key’ to his speedy recovery.

The antibody treatment has already been authorized by the FDA to treat mild to moderate cases of COVID-19 and pediatric patients 12 years or older at high risk of severe disease.

New trial showed the Regeneron's antibody cocktail reduced the overall risk of symptomatic infection by 31% and by 76% after the third day (above)

New trial showed the Regeneron’s antibody cocktail reduced the overall risk of symptomatic infection by 31% and by 76% after the third day (above)

Regeneron's cocktail, a mixture of two drugs, imitates antibodies that the body generates when fighting the coronavirus in order to boost the immune system

Regeneron’s cocktail, a mixture of two drugs, imitates antibodies that the body generates when fighting the coronavirus in order to boost the immune system

It was given to former President Donald Trump when he was infected with COVID-19 in October 2020, and which he hailed as 'key' to his speedy recovery. Pictured: Trump returns to the White House after being treated at Walter Reed, October 2020

It was given to former President Donald Trump when he was infected with COVID-19 in October 2020, and which he hailed as ‘key’ to his speedy recovery. Pictured: Trump returns to the White House after being treated at Walter Reed, October 2020

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‘COVID-19 transmission often occurs via infected people who do not yet have symptoms, so it is critical that we rapidly diagnose and treat these individuals for their own health and to prevent transmission,’ said co-principal investigator Dr Katharine Bar, an assistant Professor of Medicine at the University of Pennsylvania, in a statement.

‘These data pave the way for REGEN-COV to be used before patients become symptomatic, with a more convenient subcutaneous administration.’ 

For the trial, the team looked a data from 204 patients with recently infected asymptomatic COVID-19 patients.

Half of the group received 1,200 milligrams (mg) of the drug and the other half received a placebo.  

The overall risk was reduced by 31 percent, with 29 patients on the treatment developing symptoms compared to 44 in the control group.

If by the third day symptoms hadn’t developed, a patient’s risk of experiencing a cough, fever, or loss of taste and smell was 76 percent less likely than that of a place placebo patient.

What’s more, no patients taking REGN-COV patients were hospitalized or visited the emergency room compared to six placebo patients.   

In addition, Regeneron said its cocktail cut the amount of viral burden, the amount of virus present, cut by more than 90 percent

Experts say that while vaccinations is the key to herd immunity, treatments are also important to ending the pandemic. 

A separate study found that REGEN-COV, protected household contacts from exposure to the virus with 72 percent protection in the first week and 93 percent after that. 

‘These Phase 3 data provide even more evidence that REGEN-COV, this time given to asymptomatic patients via convenient injections, can change the course of COVID-19 infection in non-hospitalized patients,’ said Dr George Yancopoulos, Chief Scientific Officer at Regeneron, in a statement.  

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‘In this trial, the REGEN-COV antibody cocktail effectively prevented asymptomatic patients from becoming symptomatic, and rapidly lowered their viral load.’

Regeneron’s partner, Roche, is making the drug at its plants in California and is responsible for sales outside the U.S.

The two companies have stated that they believe they can produce more than two million doses of the cocktail annually.



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