The United States Food and Drug Administration on Saturday issued an emergency use authorisation for Regeneron Pharmaceutical ’s Covid-19 a...
The United States Food and Drug Administration on Saturday issued an emergency use authorisation for Regeneron Pharmaceutical’s Covid-19 antibody therapy, an experimental treatment that was administered to President Donald Trump shortly after he tested positive for coronavirus.
The treatment is a cocktail of two powerful antibodies, Casirivimab and Imdevimab, which must be administered together by intravenous infusion. Early studies showed the therapy was effective in keeping the Covid-19 infection in check and reducing medical visits in patients who get the drug early in the course of their disease, FDA said.
“Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” said Stephen Hahn, commissioner of the Food and Drug Administration.
The emergency authorisation for Regeneron’s drug is, however, limited in scope. It is primarily for those aged 12 and over who have tested positive for the coronavirus and are at high risk for developing severe Covid-19. The drug is not authorised for use in people who are hospitalised or who need oxygen.
Dr George D Yancopoulos, Regeneron’s president and chief scientific officer, said in a statement that he was encouraged by the recent vaccine results, but “there remains a need to treat patients who develop Covid-19, especially as some may not have...
