Regeneron’s Antibody Treatment Gets FDA Emergency Authorization
On Saturday the FDA granted emergency use authorization for REGN-COV2, Regeneron's therapy that is a cocktail of two monoclonal antibodies. While the drug was still experimental it was given to President Donald Trump.
Politico:
FDA Grants Emergency Use Of Covid Treatment Given To Trump
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. (Brennan, 11/21)
NPR:
FDA Grants Emergency Authorization For COVID-19 Treatment From Regeneron
The treatment combines two antibodies — casirivimab and imdevimab — and administers them together by IV. In a clinical trial of about 800 people, the combination was shown to significantly reduce virus levels within days of treatment. In its authorization on Saturday, the FDA made clear that the drug is only for the treatment of mild to moderate COVID-19 in people 12 years and older who are at high risk of developing more severe symptoms. It's not for patients who are hospitalized because of COVID-19 or who require oxygen therapy because of the virus. (Schwartz, 11/22)
The New York Times:
F.D.A. Grants Emergency Authorization Of Antibody Treatment Given To Trump
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. (Thomas Weiland, 11/21)
AP:
FDA Allows Emergency Use Of Antibody Drug Trump Received
Regeneron said that initial doses will be made available to roughly 300,000 patients through a federal government allocation program. Those patients will not be charged for the drug but may have to pay part of the cost of giving the IV. (Marchione, 11/22)
