Sumary of FDA authorizes lower dose of Regeneron antibody cocktail for COVID-19:
- The FDA has authorized a lower dose of Regeneron antibody cocktail to treat COVID-19, which the company said may help more patients access the treatment..
- The updated EUA also allows the cocktail, called REGEN-COV, to be delivered subcutaneously “when IV infusion is not feasible and would lead to a delay in treatment.”.
- government to treat patients aged 12 years or older with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death..
- “Despite increased use of vaccines, thousands of patients are still becoming infected in the United States every day, with many at high risk of serious complications from COVID-19..
- Unfortunately, to date, only a fraction of patients eligible for antibody treatments have received them, which we hope will change based on this updated FDA authorization,”.
- The updated EUA was based on the results of several trials, including a phase 3 trial that was presented recently at the American Thoracic Society International Conference that demonstrated a consistent treatment effect between the two doses..
- In its treatment guidelines, the Infectious Diseases Society of America suggests using REGEN-COV or another antibody cocktail containing bamlanivimab and etesevimab to treat ambulatory patients with mild-to-moderate COVID-19 who are at risk for progression to severe disease…