Regeneron’s COVID-19 therapy was found to reduce the risk of death in hospitalized patients who had not mounted their own immune response to the virus by up to 20%, the company said Wednesday. The drug, REGEN-COV, was being tested in the UK RECOVERY trial and was given to patients in addition to usual care.
The company said it plans to submit the data “immediately” to the FDA in a bid to expand the current emergency use authorization. Currently, the monoclonal antibody cocktail is not authorized for use in patients who are hospitalized due to COVID-19 or require oxygen therapy.
In the current trial, REGEN-COV was shown to rapidly reduce viral levels in hospitalized patients, and lowered risk of death or need for mechanical ventilation, primarily in patients whose immune system did not mount a natural antibody response.
The trial showed that adding 8,000 mg of REGEN-COV to usual care was found to reduce all-cause mortality in seronegative patients by 29% compared to usual care alone. The median duration of hospital stay among this patient population was also four days shorter, and the proportion of patients discharged by day 28 was greater.
“These results are very exciting,” Sir Peter Horby, professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, and joint chief investigator for the RECOVERY trial, said in a news release. “There was, however, great uncertainty about the value of antiviral therapies in late-stage COVID-19 disease. It is wonderful to learn that even in advanced COVID-19 disease, targeting the virus can reduce mortality in patients who have failed to mount an antibody response of their own.”