The World Health Organization has recommended therapy with Regeneron’s REGEN-COV monoclonal antibody for two groups of patients vulnerable to severe COVID-19 outcomes.
The treatment, which combines the drugs casirivimab and imdevimab, is recommended for patients with non-severe COVID-19 who are at highest risk of hospitalization and for those with severe or critical covid-19 who are seronegative (have not produced their own antibodies to SARS-CoV-2).
Other COVID-19 patients are unlikely to benefit from the treatment, according to the WHO Guideline Development Group, a panel of international experts and patients.
The recommendations are not as far-reaching as those from the U.S. Food and Drug Administration, which has steadily increased its allowances for the drug. REGEN-COV not only authorized for use in non-hospitalized patients already ill with the disease. It can now be used as a preventive drug, covering highly vulnerable patients in the time between exposure to the virus and development of illness.
In June, the FDA also approved a reduced dose of the therapy and subcutaneous injections of the drug when intravenous infusion is not possible.
The WHO recommendation for patients with non-severe COVID-19 is based on new evidence from three trials that have yet to be peer reviewed. These have shown that REGEN-COV is likely to reduce the risk of hospitalization and symptom duration in older adults and unvaccinated or immunosuppressed patients.
The recommendations are part of a guideline published in the BMJ.