Phase 3 Trial Shows REGEN-COV™ (casirivimab with imdevimab) Antibody Cocktail Reduced Hospitalization or Death by 70% in Non-hospitalized COVID-19 Patients

TARRYTOWN, N.Y., March 23, 2021 /PRNewswire/ -- 

REGEN-COV also significantly shortened the duration of symptoms by 4 days

All doses (8,000 mg, 2,400 mg and 1,200 mg) had similar efficacy across all endpoints

Companion dose-ranging Phase 2 trial showed significant and comparable viral reductions for all REGEN-COV doses tested, including as low as 300 mg

FDA recently updated U.S. EUA fact sheets for all authorized monoclonal antibody treatments, indicating that REGEN-COV is the only one to retain potency against key emerging variants

Regeneron will share new data with regulatory authorities immediately and request that a lower 1,200 mg dose be added to EUA

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalized patients (n=4,567). This definitive Phase 3 outcomes trial in high-risk non-hospitalized COVID-19 patients ("outpatients") met its primary endpoint, showing the investigational REGEN-COV™ (casirivimab with imdevimab) significantly reduced the risk of hospitalization or death by 70% (1,200 mg intravenous [IV]) and 71% (2,400 mg IV) compared to placebo.

"This is a landmark moment in the fight against COVID-19 as this large well-controlled trial provides conclusive results demonstrating that REGEN-COV can dramatically reduce the risk of hospitalization and death in the outpatient setting," said Suraj Saggar, D.O., trial investigator and Chief of Infectious Disease at Holy Name Medical Center in Teaneck, New Jersey. "With so many people still getting infected, as well as recent data showing that REGEN-COV addresses emerging variants, these data underscore the need to rapidly adopt REGEN-COV as standard-of-care to offer high-risk patients their best chance to reduce serious consequences like hospitalization or death."

REGEN-COV also met all secondary endpoints in the Phase 3 outcomes trial, including the ability to reduce symptom duration. In addition, a companion Phase 2 trial showed that even the lowest doses tested (IV: 300 mg; subcutaneous [SC]: 600 mg) had significant viral load reductions over the first 7 study days, comparable to the 2,400 mg and 1,200 mg IV doses.

"With approximately 60,000 newly diagnosed individuals in the U.S. every day and 40,000 still in the hospital because of COVID-19, we are committed to working with the government, healthcare providers and others to support rapid and widespread adoption of REGEN-COV in appropriate patients," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "We will discuss the new data with regulatory authorities and request that the 1,200 mg dose be rapidly added to the U.S. Emergency Use Authorization, in order for the anticipated REGEN-COV supply to be available to treat even more patients. These Phase 3 data will also form the basis of a full Biologics License Application."