Regeneron Pharmaceuticals, Inc. announced today 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.
“With these clear new NIH guidelines, Emergency Use Authorization from the U.S. Food and Drug Administration, ample supply of REGEN-COV, and the medicine being supplied free of charge by the U.S. government, the time for equivocation has passed — we must now all do whatever it takes to make sure appropriate patients are treated as early as possible after diagnosis,” said Leonard S. Schleifer, M.D., Ph.D., President and CEO at Regeneron. “If we work together, we can avoid tens of thousands of needless hospitalizations or deaths from COVID-19. We will also continue to partner with stakeholders to address other key bottlenecks such as education, ease of administration and better systems to ensure infusion reimbursement.”
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) recently 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.
“Regeneron continues to innovate to respond to this devastating pandemic. With approximately 60,000 new infections daily, many of them in high-risk individuals, it’s clear there is an urgent need to improve access to treatments like REGEN-COV that are proven to reduce hospitalization or death,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. “In addition to working to advance simpler subcutaneous administration of REGEN-COV, we look forward to sharing additional data soon on the use of REGEN-COV to prevent infection.”
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.
The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.