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. 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 would 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. Although the first 300,000 doses will be provided for free, patients may be charged for having the treatment administered; it must be infused in a clinic or a 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 take weeks for the F.D.A. to consider the applications, and if it issues approvals, access will be limited to people in high-risk groups.
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 had access to or were not protected by vaccination.”
Regeneron enjoyed a burst of publicity in October, when Mr. Trump received an infusion of its cocktail and then enthusiastically promoted the drug as something that had lent him a superpower-like feeling. In a video released on Oct. 7, the president claimed without evidence that it had cured him, and that he had authorized it — something he does not have the power to do.
It remains impossible to know whether the Regeneron treatment helped Mr. Trump. He was given multiple drugs while at Walter Reed National Military Medical Center, and many people recover from the virus on their own.
Source : Nytimes
