Antibody treatment gets emergency use approval from FDA

The Food and Drug Administration has granted emergency authorization for the experimental antibody treatment given to President Trump shortly after he was diagnosed with COVID19, providing doctors another option to treat COVID19 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 COVID19. Evidence so far suggests that antibody treatments work best 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 COVID19 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 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 free, 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 bridge until a coronavirus vaccine is more broadly available. Pfizer, which has completed its trial, submitted an application Friday for emergency authorization of the vaccine, and Moderna said it planned to apply soon. Still, it will be weeks before a vaccine is available, and even then, access will be limited to people in highrisk groups.

In addition to Regeneron’s deal with the federal government, Eli Lilly announced a $ 375 million deal in October to supply the government with 300,000 doses.