The EMA have stopped a rolling review of the marketing authorisation application for the antibodies bamlanivimab and etesevimab by Eli Lilly Netherlands, to treat COVID-19. This follows the company withdrawing from the process, citing a lack of demand from EU member states.
The company have stated that “At this point Lilly is not in a position to generate the additional data required by the CHMP to progress to a formal marketing authorisation application.”
Bamlanivimab and etesevimab are intended for use in COVID patients at high risk of disease progression aged 12 years and above who do not need supplemental oxygen. The US had already granted emergency approval for the antibody cocktail to prevent deterioration and in some cases of exposure to the virus. The antibodies bind to the spike protein of the coronavirus at two different sites, which stops the virus from entering the body’s cells.
At the time of the withdrawal, the EMA was assessing the data of the cocktail drug under a rolling review process, and had received non-clinical, clinical trial, and quality and manufacturing process data of the combination therapy and the risk management plan when the application was withdrawn.
The company retains the right to request another rolling review or to submit a marketing authorisation application in the future. In September, Lilly signed a joint procurement deal with the European Commission (EC) to deliver up to 220,000 doses of the antibodies to treat COVID patients. The deal allows access to therapies for participating EU and EEA countries. Those participating are able to purchase bamlanivimab and etesevimab directly, once they receive emergency use approval or marketing authorisation at EU level.
