Regeneron Pharmaceuticals (NSDQ:REGN) announced today that its COVID-19 antibody drug reduced hospitalization and death risk by 70% in clinical trials.
The definitive Phase 3 outcomes trial in high-risk, non-hospitalized COVID-19 patients met its primary endpoint in displaying that the 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 by placebo, according to a news release.
REGEN-COV also met all secondary endpoints, which included a reduction in symptom duration. Additionally, a companion trial showed that the lowest dose (300 mg IV/600 mg subcutaneous) had significant viral load reductions over the first seven days, even reaching a level comparable to the highest performing doses (2,400 mg and 1,200 mg IV doses).
“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,” Holy Name Medical Center (N.J.) chief of infectious disease and trial investigator Dr. Suraj Saggar said in the release. “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.”
The FDA in November issued emergency use authorization (EUA) for the REGEN-COV treatment. Then-President Donald Trump was treated with the drug while it was under investigational use in October 2020 when he was hospitalized with COVID-19.
“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,” added Regeneron presdient & CEO Dr. George D. Yancopoulos. “We will discuss the new data with regulatory authorities and request that the 1,200 mg dose be rapidly added to the [EUA], 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.”
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease