Adagio Plans to Submit EUA Application for COVID-19 Investigational Drug Adintrevimab

Adagio Therapeutics said it plans to file for an Emergency Use Authorization (EUA) from the FDA for its investigational monoclonal antibody, adintrevimab, for both prevention and treatment of COVID-19.

The filing will be supported by positive data from two phase 2/3 clinical trials that included a pre-exposure prophylaxis (PrEP) cohort and a postexposure prophylaxis (PEP) cohort. In both studies, participants who received a 300-mg dose of adintrevimab for prevention showed a lower incidence of symptomatic COVID-19 infection compared with those given a placebo. And in the postexposure cohort, adintrevimab was associated with a lower risk of disease-related hospitalization.

The phase 2/3 studies were primarily conducted before the Omicron variant became the dominant variant. The company said it plans to file for an EUA in the second quarter of 2022.