Lilly Withdraws COVID-19 Antibody Combo from EMA’s Rolling Review
The decision to no longer pursue the marketing authorisation application for bamlanivimab and etesevimab is due to the CHMP’s requirement for validation data, which the company states can only be generated by manufacturing new batches of active substance and which is not needed based on the company’s supply forecasts.
Eli Lilly has no on-going clinical trials in the EU with bamlanivimab and etesevimab.
The EMA states the withdrawal has no consequences on the previous advice issued and patients may continue to receive the antibodies based on national arrangements.
The company withdrew from the process shortly after the start of the sixth rolling review cycle, which included data from ongoing clinical studies, further data on the quality and manufacturing process of the antibodies and an updated version of a proposed risk management plan.