F.D.A. Grants Emergency Authorization of Antibody Treatment Given to Trump
The treatment, made by the biotech company Regeneron, is a cocktail of two powerful antibodies that have shown promise for people who get it early in the course of the disease.
Regeneron’s headquarters in Tarrytown, N.Y.
Regeneron’s headquarters in Tarrytown, N.Y.Credit…Melissa Bunni Elian for The New York Times
By Katie Thomas and Noah Weiland
Nov. 21, 2020Updated 8:53 p.m. ET
The Food and Drug Administration has granted emergency authorization for the experimental antibody treatment given to President Trump shortly after he was diagnosed with Covid-19, giving doctors another option to treat Covid-19 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 in 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 12 and over who have tested positive for the coronavirus and who are at high risk for developing severe Covid-19. Evidence so far suggests that antibody treatments work 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 as an average of more than 168,000 people are diagnosed each day with Covid-19 in the United States and hospitals are running out of beds in some regions of the country. Regeneron has said it will have enough of the drug for only about 80,000 people by the end of November, enough for 200,000 patients by the first week of January, and 300,000 by the end of January. After that, the company said it will be able to ramp up production thanks to a partnership with the Swiss manufacturer Roche.
Regeneron has received more than $500 million from the federal government to develop and manufacture the treatments, a complex and time-consuming process. Although the first 300,000 doses will be provided free of charge, patients may be charged for having the treatment administered; it must be infused in a clinic or hospital.
Antibody treatments have gotten less attention than vaccines, but health officials have long held out hope that they may serve as a possible bridge until a coronavirus vaccine is more broadly available. Two vaccines, one made by Pfizer and another by Moderna, were recently shown to be more than 90 percent effective in early analyses. Pfizer, which has completed its trial, submitted an application on Friday for emergency authorization of the vaccine, and Moderna said it also planned to apply soon. Still, it will be weeks before a vaccine is available, and even then, access will be limited to people in high-risk groups.
The New York Times