By Tony Winterburn • 22 November 2020 • 9:54
FDA Approves Regeneron COVID Drug Given to Trump he Touted as ‘Cure’.
The Food and Drug Administration (FDA) on Saturday, November 21 granted an emergency use authorisation for Regeneron’s Covid-19 antibody treatment. President Trump was given the experimental therapy when he contracted the coronavirus in October.
Regeneron submitted an emergency use application that month after preclinical studies showed that the therapy, called REGN-COV2, reduced the amount of virus and associated damage in the lungs of non-human primates. The company said trial data also shows the drug reduces medical visits in patients with mild-to-moderate Covid-19.
“The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic. Authorising these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” said FDA Commissioner Stephen M. Hahn.
The agency said the data supporting Regeneron’s emergency use authorisation came from a clinical trial in 799 non-hospitalised patients with mild to moderate symptoms of COVID-19. For patients who were at high risk because of a variety of underlying conditions – from obesity to old age to diabetes – hospitalisation and emergency room visits occurred in three per cent of patients who received the intravenous treatment. This was compared to nine per cent in placebo-treated patients.
Leonard Schleifer, Regeneron’s president and CEO, said the FDA authorisation was “an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection”.
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