Regeneron's REGEN-COV2 receives EUA

US Biotech Regeneron Pharmaceuticals (Nasdaq: REGN) on Saturday revealed that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the US Food and Drug Administration.

The experimental treatment was given to US President Donald Trump, who said it helped cure him of the disease he contracted in October this year. A similar antibody treatment, from Eli Lilly (NYSE: LLY), was also granted emergency approval earlier this month.

Casirivimab and imdevimab administered together are authorized for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization. The clinical evidence from Regeneron's outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.