The European Medicines Agency (EMA) announced on Wednesday 3 November that it had terminated the rolling review of the Covid-19 treatment candidate from the US pharmaceutical company Eli Lilly.
Identified by the European Commission as one of the most promising therapeutic solutions for SARS-CoV-2 (see EUROPE 12819/21), this potential treatment, combining the antibodies bamlanivimab and etesevimab, had been the subject of a European advance purchase agreement for up to 220,000 doses. At the time, 18 Member States expressed interest in this potential treatment (see EUROPE 12795/19).
A marketing authorisation application had already been submitted by the company to the EMA. However, Eli Lilly has withdrawn this request and requested to withdraw from the proceedings.
This decision came after the committee responsible for preparing the European agency’s opinions on human medicines (CHMP) required that the company provide new validation data.
In a letter to the EMA on Friday 29 October, the pharmaceutical company explained that it was “not in a position to generate the additional data required by the CHMP to progress to a formal marketing authorisation application”.
Generating this data would have required the production of new batches of active substance - production which the company did not consider “needed for the foreseeable future”, “given the current demand from EU Member States”.
However, the company retains the right to apply for a further rolling review or to submit an application for a European marketing authorisation in the future.
For the time being, it continues to supply the United States. On Tuesday 2 November, it announced an additional delivery of 614,000 doses of its treatment to the US government by 31 January 2022.
To read the letter to the EMA: https://bit.ly/3k2qEbu (Original version in French by Agathe Cherki)