Antibody Therapy Shown To Reduce Risk Of Death In COVID-19 Patients, Seeks FDA Approval
An antibody treatment has been shown to reduce mortality in patients hospitalized with severe COVID-19 by 20%, researchers at Regeneron Pharmaceuticals said Wednesday.
The drug, REGEN-COV, was shown to be effective in seronegative patients, or patients who do not produce natural antibodies to the coronavirus, according to the results of Regeneron’s clinical trial released Wednesday. Seronegative patients typically have double the mortality rates of patients who are able to produce antibodies to the coronavirus, according to the study.
The treatment is an intravenous infusion of two lab-created antibodies that target the spike protein of COVID-19 and prevent it from entering cells.
“Giving them this combination of two antibodies by an intravenous infusion then actually reduces their chances of dying by a fifth,” one of the study’s head researchers Sir Martin Landray said in a statement Wednesday. “These patients are among the sickest patients, and we have a treatment we didn’t have before.”
RECOVERY Result:
Monoclonal antibody combination reduces deaths for hospitalised patients with COVID-19 who haven't produced antibodies for themselves.
Mortality reduced by one-fifth (30% -> 24%)
A new treatment for the sickest patients!
Pre-print submitted – out later today pic.twitter.com/HNUdQbXciX
— Martin Landray (@MartinLandray) June 16, 2021
The study, part of the larger RECOVERY trial that explores COVID-19 treatments, involved 9,785 hospitalized patients of whom a third were seronegative. Though the drug reduced the risk of death in seronegative patients by 20%, it had no effect on patients already producing antibodies.
“It is wonderful to learn that even in advanced COVID-19 disease, targeting the virus can reduce mortality in patients who have failed to mount an antibody response of their own,” said Sir Peter Horby, one of the RECOVERY trial’s lead researchers, in a statement Wednesday.
While the drug is already authorized by the Food and Drug Administration for emergency use in mild to moderate cases of COVID-19, Regeneron is seeking approval for the drug to be administered to treat more severe cases.
“Regeneron is in discussions with the FDA to expand the current Emergency Use Authorization to other populations, including the prevention and hospitalized patient settings,” the company announced in their statement.
If approved, the drug would be the first antibody treatment to be authorized for treating severe cases of COVID-19, according to The Wall Street Journal.
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