FDA Expands EUA for Lower Dose Subcutaneous Version of Regeneron's COVID-19 Antibody Cocktail

The FDA has authorized a new, lower-dose version of Regeneron Pharmaceuticals Inc’s REGN COVID-19 monoclonal antibody cocktail for those with COVID-19 who are at high risk of progressing to hospitalization.
The agency updated the Emergency Use Authorization (EUA) for REGEN-COV, lowering the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab),
Regeneron said in a statement that the combo “should be administered by intravenous (IV) infusion” and subcutaneous injections “are an alternative when IV infusion is not feasible and would lead to a delay in treatment.”
The EUA is supported by pivotal Phase 3 data showing 1,200 mg dose reduced risk of hospitalization or death by 70%
In addition, in vitro research has shown that REGEN-COV retains potency against the main variants of concern circulating within the U.S., including the P.1 variant and the B.1.351 variant.
Later this summer, Regeneron expects to submit a full marketing application for the combo treatment for the same indication in non-hospitalized outpatients with COVID-19.
In addition to outpatients, REGEN-COV is also being evaluated in prevention and certain hospitalized COVID-19 patient settings.
Price Action: REGN shares are up 2.33% at $517.43 during the market session on the last check Friday.