The approval is the latest in a series of victories for Regeneron after its treatment received approval in the United Kingdom, Japan and Australia. The authorization allows Regeneron to market its product to individuals aged 12 years and older for outpatient treatment and for individuals with an increased risk of developing severe symptoms.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use issued a positive opinion of the treatment on Thursday.
“This approval adds to the growing number of countries that have recognized our antibody cocktail as an important therapy against COVID-19 to treat non-hospitalized patients already infected with the virus and to prevent infection in the first place,” said George D. Yancopoulos, president and chief scientific officer of Regeneron.
“With today’s approval, we hope countries in the European Union will accelerate their adoption of this formidable tool to reduce the burden of COVID-19,” he added.
The commission’s approval is based on two positive Phase 3 trials involving more than 6,000 individuals evaluated for efficacy and safety of the cocktail to treat non-hospitalized patients infected with the coronavirus.
The approval also followed the results of a clinical trial run by Regeneron in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) that found the antibody cocktail reduces the risk of COVID-19 infection by nearly 82% for at least eight months.
“During the 8-month assessment period, there were 0 hospitalizations for COVID-19 in the REGEN-COV group and 6 in the placebo group,” Regeneron said in a press release. “The fully human antibodies in REGEN-COV were developed to provide long-lasting protective effects without any artificial mutations or sequences.”
No deaths occurred either.
The U.S. Food and Drug Administration (FDA) has not yet approved the antibody cocktail, but has authorized its use for treatment and post-exposure regimens in certain high-risk individuals.
Regeneron recently submitted two different Biologics License Applications, which the FDA accepted, for use in non-hospitalized patient treatment and in cases of hospitalization.