On 2 November 2021, the European Medicines Agency (EMA) ended the rolling review process of Eli Lilly's anti-COVID-19 bamlanivimab/etesevimab monoclonal antibody cocktail after Eli Lilly had withdrawn its application.
Since March 2021, the Committee for Medicinal Products for Human Use (CHMP) had been assessing data on the bamlanivimab/etesevimab monoclonal antibody combination in a rolling review. The company Eli Lilly had been submitting data on this on an ongoing basis as it became available, in order to accelerate the evaluation of the antibody cocktail.
In March 2021, the EMA has made a recommendation for the treatment of COVID-19 based on data from a clinical trial. This recommendation has been supporting the use of the antibodies at a national level prior to marketing authorisation.
The withdrawal was the company’s decision. It means that the EMA is no longer reviewing the data on these antibodies and will not complete this review.
The withdrawal does not affect the previous recommendation from March: patients can continue to receive the medicines based on national regulations.
The CHMP will continue to review data on COVID-19 vaccines and treatments under accelerated conditions during the ongoing pandemic.
Updated: 03.11.2021
