Regeneron Pharmaceuticals plans to request the US Food and Drug Administration (FDA) to approve the use of its COVID-19 monoclonal antibody cocktail as a preventative treatment.
Data from a Phase III clinical trial, conducted in conjunction with the National Institutes of Health, found the drug reduced the risk of asymptomatic coronavirus patients developing symptoms by day three by 76 percent.
The treatment is a mixture of casirivimab and imdevimab and was developed by the New York City-based company in partnership with pharmaceutical company Roche.
The cocktail known as REGEN-COV mimics antibodies the body makes when fighting the virus to help boost the immune system.
The cocktail was given to former President Donald Trump when he was infected with COVID-19 in October 2020, and he called it the “key” to his speedy recovery.
The antibody treatment has already been approved by the FDA for the treatment of mild to moderate cases of COVID-19 and pediatric patients 12 years and older at high risk for serious illness.
New study showed that the Regeneron antibody cocktail reduced the overall risk of symptomatic infection by 31% after the third day and by 76% after the third day (see above).
Regeneron’s Cocktail, a mixture of two drugs, mimics antibodies the body makes when fighting the coronavirus to help 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 described as the “key” to his speedy recovery. Pictured: Trump returns to the White House after receiving treatment at Walter Reed in October 2020
“COVID-19 is often transmitted through infected people who have not yet experienced symptoms. So it is important that we diagnose and treat these people quickly to ensure their own health and prevent transmission,” said the 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 route.”
For the study, the team looked at data from 204 patients with recently infected asymptomatic COVID-19 patients.
Half of the group received 1,200 milligrams (mg) of the drug and half received a placebo.
The overall risk was reduced by 31 percent, with 29 patients developing symptoms during treatment compared with 44 in the control group.
If no symptoms developed on day three, a patient’s risk of having a cough, fever, or loss of taste and smell was 76 percent lower than that of a placebo patient.
In addition, compared to six placebo patients, no patients taking REGN-COV patients were hospitalized or taken to the emergency room.
In addition, Regeneron said his cocktail reduced the amount of viral load, the amount of virus present, by more than 90 percent
Experts say that while vaccinations are key to herd immunity, treatments are also important in ending the pandemic.
A separate study found that REGEN-COV protected household contacts from exposure to the virus with 72 percent protection the first week and 93 percent thereafter.
“These Phase 3 data provide even more evidence that REGEN-COV, this time given via convenient injections to asymptomatic patients, can alter the course of COVID-19 infection in out-of-hospital patients,” said Dr. George Yancopoulos, Scientific Director at Regeneron, in a statement.
“In this study, the REGEN-COV antibody cocktail was effective in preventing asymptomatic patients from becoming symptomatic and quickly reducing their viral load.”
Regeneron’s partner Roche manufactures the drug in its California facilities and is responsible for sales outside the United States
The two companies have stated that they believe they can produce more than two million cans of the cocktail annually.