EMA’s human medicines committee (CHMP) is reviewing available data on the use of the monoclonal antibodies casirivimab, imdevimab, bamlanivimab and etesevimab to treat patients with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. The committee will carry out two separate reviews, one for the casirivimab/imdevimab combination and another for bamlanivimab/etesevimab.
EMA is reviewing the data to provide a harmonised scientific opinion at EU level to support national decision making on the possible use of the antibodies before a formal authorisation is issued. Earlier this week, EMA already started a rolling review of the antibody combination casirivimab and imdevimab.
The reviews have been started in view of recent studies that looked into the effects of the combinations casirivimab/imdevimab and bamlanivimab/etesevimab in outpatients with COVID-19 who do not need supplemental oxygen. Preliminary results for both studies indicate that the combinations reduced the viral load (amount of virus in the back of the nose and throat) more than placebo (a dummy treatment) and led to fewer COVID-19-related medical visits and hospitalisations.
The Committee will also look at the use of bamlanivimab alone based on a study which indicated that bamlanivimab monotherapy can reduce viral load and provide clinical benefit.
EMA will communicate further when it has reviewed all the data.