As U.S. communities gradually return to normalcy, thousands of patients are still becoming infected, with many at high risk of serious complications from COVID-19.
Today Regeneron announced the FDA updated its Emergency Use Authorization (EUA) for REGEN-COV (casirivimab and imdevimab), an antibody cocktail to treat patients with COVID-19:
- The FDA authorized a lower dose (1,200 mg) – half the originally authorized dose – that can be administered as an IV infusion or notably, subcutaneous injection when IV infusion is not feasible and would lead to a delay in treatment.
- REGEN-COV is now authorized as a co-formulated single vial, which will be made available in the coming weeks.
- This EUA follows an update in May, where the patient eligibility criteria for REGEN-COV was expanded. HCPs may now consider certain medical conditions as well as other factors (for example, race or ethnicity) to assess whether a patient is high risk.
- Separately, REGEN-COV is the only antibody therapy currently available in all 50 states, including eight states with high rates of two variants of concern (Arizona, California, Florida, Illinois, Indiana, Massachusetts, Oregon and Washington)