On Apr. 9, 2021, Regeneron 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.

Despite the strong progress being made with vaccination, in the U.S. approximately 2 million people a month are still diagnosed with COVID-19 and tens of thousands are at risk of dying from COVID-19.

Importantly, some NIH panel members recommended REGEN-COV as the preferred antibody cocktail for COVID-19 in areas where variants are common, given REGEN-COV’s continued potency in vitro against the variants first identified in the United Kingdom, Brazil, South Africa, New York and California, while acknowledging that it is not known whether in vitro susceptibility data correlates with clinical outcomes.

The U.S. Food and Drug Administration (FDA) authorized updated Emergency Use Authorization (EUA) fact sheets for all authorized monoclonal antibody treatments, which indicate that REGEN-COV is the only therapy to retain potency against these key emerging variants. In many parts of the U.S., variants now make up the majority of all new COVID-19 cases.