The Food and Drug Administration has granted emergency authorization for the experimental antibody treatment given to President Trump shortly after he tested positive for the coronavirus, giving doctors another option to treat patients as cases across the country continue to rise.
The treatment, made by the biotech company Regeneron, is a cocktail of two powerful antibodies that have shown promise in early studies at keeping the infection in check, reducing medical visits for patients who get the drug early in the course of their disease. A similar treatment, made by Eli Lilly, was given emergency approval earlier this month.
The emergency authorization for Regeneron’s drug is limited in scope: It is for people who have tested positive for the coronavirus and who are at high risk for developing severe Covid-19. And evidence so far suggests that Regeneron’s antibody treatment, like Eli Lilly’s, works best early in the course of the disease, before the virus has gained a foothold in the body. Like Eli Lilly’s treatment, Regeneron’s is not authorized for use in people who are hospitalized or who need oxygen.
The emergency authorization raises immediate questions about who will get access to the treatments. An average of more than 168,000 coronavirus cases are reported each day in the United States, and hospitals are running out of beds in some regions of the country.
Source: NYT