Regeneron COVID Antibody Treatment Gets Emergency Use Authorization from the FDA

the staff of the Ridgewood blog

Ridgewood NJ, according to Johns Hopkins Center for Health Security , the US FDA issued an Emergency Use Authorization (EUA) for another monoclonal antibody treatment for COVID-19. The newest EUA is for a combination therapy using casirivimab and imdevimab, developed by Regeneron Pharmaceuticals, which are monoclonal antibodies that target the receptor binding domain for the SARS-CoV-2 spike protein. Similar to the previous FDA EUA for the Eli Lilly monoclonal antibody treatment, this combination is authorized for use in mild or moderate COVID-19 patients (aged 12 years and older) who are not currently hospitalized but who are at high risk of progressing to severe disease. It is not authorized for patients who are currently hospitalized or receiving supplemental oxygen therapy for COVID-19 or an underlying health condition. The 2 products must be administered together.

Reportedly, US President Donald Trump received the combination therapy when he was diagnosed with COVID-19 in October under a Compassionate Use protocol, as the treatment had no formal authorization from the FDA at that time. Regeneron indicated that it expects to have enough supply to treat 80,000 patients by the end of the month; 200,000 by early January 2021; and 300,000 by the end of January. Additionally, Regeneron is partnering with Roche Pharmaceuticals to increase production capacity in early 2021.