Regeneron Pharmaceuticals, Inc. announced that newly updated National Institutes of Health (NIH) COVID-19 Treatment Guidelines strongly recommend that REGEN-COV™ (casirivimab with imdevimab) be used in non-hospitalized COVID-19 patients (“outpatients”) at high risk of clinical progression. The Category ‘AIIa’ is a ‘strong’ rating based on results of randomized trials.
The recommendation from the NIH COVID-19 Treatments Guidelines Panel is a critical step in helping make monoclonal antibody therapies like REGEN-COV available for all appropriate patients in the U.S. The new guidelines are based in part on robust clinical data involving more than 4,500 outpatients showing that REGEN-COV significantly reduced the risk of hospitalization or death by 70% compared to placebo.
Although REGEN-COV is not currently recommended for people hospitalized due to COVID-19, the panel recommended that REGEN-COV use should be considered for persons with mild-to-moderate COVID-19 who are hospitalized for a reason other than COVID-19 but who otherwise meet the EUA criteria.