EMA concludes evaluation of Lilly’s monoclonal antibodies against COVID-19

The European Medicines Agency (EMA) announced on Wednesday that it is ending the evaluation of the treatment of COVID-19 with monoclonal antibodies developed by the US pharmaceutical Eli Lilly, after the company has withdrawn from the process.

The European regulator began last March a real-time analysis of the data that were becoming available on the antibodies bamlanivimab and etesemivab, used as a combination for the treatment of COVID-19 in infected people, but had not yet received enough data to confirm its safety, efficacy and quality.

“At the time of the company’s withdrawal, the EMA had received non-clinical (laboratory) data, data from clinical studies, data on the quality and manufacturing process of the antibodies and the risk management plan (RMP), ”the agency noted.

The EMA’s Committee for Human Medicines (CHMP) still had doubts about some issues regarding the quality of treatment, intended for people over 12 years of age who do not require additional oxygen or are at increased risk of developing COVID-19 grave.

The EMA underlines that the end of the drug evaluation is “a decision of the company”, which considered that it is not in a position to generate the additional data required by the CHMP for a “prospective simultaneous validation” that allows it to officially apply for a license. for use in the European Union (EU).

“Lilly anticipates that no new or additional drug manufacturing drives will be needed for the foreseeable future. Therefore, at this time, Lilly is not in a position to generate the additional data required by the CHMP, “the company itself explained in a statement.

The CHMP has already provided a positive scientific opinion on the use of the monoclonal antibody combination bamlanivimab and etesevimab, and casirivimab and imdevimab, with the aim of providing a harmonized vision in EU countries pending the completion of the evaluations requested by the laboratories and an official European license is issued.

The EMA maintains that the withdrawal of Lilly from the process has no consequences on that scientific opinion issued last March and the patients in the EU they can continue to receive the drugs based on agreements made at national levels.

It is the second time in less than a month that this scenario has occurred. The EMA already ended the evaluation of the data of the COVID-19 vaccine developed by the German CureVac in mid-October, after this pharmaceutical company has abandoned the process to focus on another more advanced vaccine against the coronavirus.