EMA Reviews Eli Lilly’s Antibody Cocktail for Treating COVID-19

The European Medicines Agency (EMA) is reviewing Eli Lilly’s antibody cocktail as a potential treatment for COVID-19 patients who don’t require supplemental oxygen and are at high risk of progressing to severe disease.

Preliminary study data on Lilly’s bamlanivimab/etesevimab cocktail showed the combination treatment reduced viral load as well as COVID-19-associated medical visits and hospitalizations and the EMA’s human medicines committee is considering a recommendation for conditional marketing authorization.

Results from a phase 3 study showed the cocktail reduced the risk of COVID-19 hospitalization or death by 70 percent. The EMA is also assessing bamlanivimab as a monotherapy and results from a late-stage study found it lowered the risk of COVID-19 infections for nursing home residents and staff by up to 80 percent (DID, Jan. 21).

Bamlanivimab received an Emergency Use Authorization (EUA) from the FDA in November for treating high-risk patients with mild-to-moderate COVID-19 who don’t require hospitalization or supplemental oxygen (DID, Nov. 10, 2020). The company’s EUA submission for bamlanivimab/etesevimab as a combination treatment is also currently under review by the FDA. ― Jason Scott