As Regeneron works to extend its antibody cocktail to patients hospitalized with COVID-19, it's also forwarding REGEN-COV as a way to keep others out of the hospital.
On Thursday, the company said the FDA granted priority review to its cocktail for two uses: to treat COVID-19 in non-hospitalized patients and to prevent infection in certain high-risk people.
The FDA set an April 13 target date for its decision, with an advisory committee meeting beforehand to discuss the application.
The submission is supported by two phase 3 trials involving more than 6,000 patients.
The antibodies have been authorized by the FDA on an emergency use basis to treat people with mild-to-moderate COVID-19 who are at high risk of progressing to severe illness and others as a post-exposure prophylaxis.
REGEN-COV is provided at no cost in the United States. The government has secured deals with the company to provide nearly 3 million doses of the cocktail at a cost of $2,100 each.
The antibodies have provided a windfall for Regeneron, which reported sales of the cocktail at $2.59 billion in the second quarter. The figure actually exceeded Regeneron’s total revenue for the first quarter ($2.53 billion).
Regeneron added that it expects to submit another application use of REGEN-COV in hospitalized patients by the end of this year. Earlier this week, the European Medicines Agency accepted Regeneron’s application for use on infected non-hospitalized patients and as a prophylaxis.
Before the emergence of REGEN-COV, antibody treatments had shown little success in helping hospitalized COVID-19 patients. But a study of 9,785 patients conducted in the U.K. showed that among those who produced no natural antibody response, REGEN-COV cut the risk of death by 20%.