BRIEF—Bamlanivimab plus etesevimab gets pediatric EUA

The US Food and Drug Administration has expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together to include pediatric patients under the age of 12, including neonates (infants <1 year old).

The EUA allows for bamlanivimab and etesevimab administered together in the treatment of mild to moderate COVID-19 as well as post-exposure prophylaxis in certain patients, says Canada’s AbCellera Biologicals.

Pseudovirus and authentic virus studies conducted by AbCellera’s partner, Eli Lilly demonstrate that bamlanivimab and etesevimab together retain neutralization activity against the Delta variant, which is currently the predominant variant of concern within the USA.

Bamlanivimab alone and/or administered with etesevimab are authorized under special use pathways in more than 22 countries. In the USA, bamlanivimab is currently only authorized for emergency use with etesevimab.