The treatment is not authorized for patients who are hospitalized due to the coronavirus or who require oxygen therapy.
The FDA on Saturday authorized the emergency use of an experimental antibody treatment from Regeneron for mild and moderate cases of the coronavirus that was given to President Donald Trump in October.
The drug is a cocktail of two monoclonal antibodies that mimic the body's natural defenses against the virus. The emergency authorization allows the drug to be used in adults and children over the age of 12 with mild to moderate Covid-19 symptoms who are at high risk of progressing to severe disease or requiring hospitalization. The treatment is not authorized for patients who are hospitalized due to the coronavirus or who require oxygen therapy.
Regeneron has published data from a late-stage trial showing that the antibody reduces the amount of virus in a person's body, and may speed recoveries.
“Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” FDA Commissioner Stephen Hahn said in a press release.
Background: President Donald Trump, who received the Regeneron antibody cocktail during his bout with Covid-19 in early October and referred to the drug as a "cure," pressured the FDA to quickly authorize such treatments. Eli Lilly also won an emergency authorization for its antibody drug earlier this month. The authorizations may make it more difficult for Regeneron and Lilly to complete their ongoing studies, and for trials of other antibody treatments to attract participants.
Supply: Regeneron says it will have enough antibody doses for about 80,000 people by the end of the month. By the first week of January, doses are expected to be available for 200,000 patients in total, and 300,000 people by the end of that month.
The Trump administration has signed a $450 million deal with Regeneron to provide up to 300,000 doses of the drug cocktail at no cost to Americans. However, health care facilities can charge fees for the administration of the treatment.
But Regeneron CEO Len Schleifer has warned that there won't be enough antibody treatment doses for everyone who needs one. Regeneron is working with Roche to boost manufacturing capacity and next year it could have as many as 2 million doses to treat Covid-19, or between 4 million and 8 million doses to help prevent people from getting sick.
What's next: The Department of Health and Human Services will begin to distribute Regeneron's antibody, potentially in a way that's similar to Lilly's antibody. The drug will be allocated on a weekly basis, and will be based on the number of coronavirus cases in each state.
Source: Politics, Policy, Political News Top Stories https://www.politico.com/news/2020/11/21/fda-grants-covid-treatment-439025