Regeneron to seek US approval for COVID-19 cocktail to be used for prevention

Regeneron is pursuing USapproval for its COVID-19 monoclonal antibody cocktail as a preventative treatment after it helped cut the risk of symptomatic infections in households where someone else is ill, the USdrugmaker said on Monday.

REGEN-COV, a combination of casirivimab and imdevimab, protected household contacts from exposure to SARS-CoV-2, with 72 per centprotection against symptomatic infections in the first week, and 93 per centafter that, according to trial data released by the company.

In a separate trial, Regeneron also said the treatment reduced overall risk of progressing to symptomatic COVID-19 by 31 per cent, and by 76 per centafter the third day.

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Regeneron has enlisted Switzerland’s Roche and its massive biotech facility in South San Francisco to make around 2 million doses annually. The cocktail already has emergency USapproval for mild to moderate COVID-19 patients, and the companies are hoping the latest trials convince regulators to expand deployment.

“These data suggest that REGEN-COV can complement widespread vaccination strategies, particularly for those at high risk of infection,” said Myron Cohen, who leads monoclonal antibody efforts for the USNational Institutes of Health-sponsored COVID Prevention Network.

A challenge in breaking infection chains, he said, is that some 10% of unvaccinated people in the study who didn’t get the Roche-Regeneron drug while living in a household with an infected individual developed symptomatic infection even with efforts to reduce transmission.

‘HIGH-RISK SETTINGS’

“REGEN-COV could help control outbreaks in high-risk settings” where people haven’t been vaccinated, Cohen said.

In the separate trial, Regeneron said the cocktail also cut symptomatic infection risk and helped nearly halve the total weeks that patients experienced symptoms, with the viral burden - the amount of virus present - cut by more than 90 per cent.

“These data pave the way for REGEN-COV to be used before patients become symptomatic,” Katharine Bar, co-principal investigator and a professor at the University of Pennsylvania hospital, said.

(With inputs from agencies)