(Reuters) – The European Union’s drug regulator said on Tuesday it had ended the rolling review of Eli Lilly’s antibody-based treatments for COVID-19, after the U.S.-based drugmaker withdrew from the process citing a lack of demand from EU member states.
Lilly’s letter to the European Medicines Agency (EMA), dated Oct. 29, said that lack of demand in the trading bloc did not justify submitting further required data on its manufacturing plan.
“At this point Lilly is not in a position to generate the additional data required by the CHMP (EMA’s human medicines committee) to progress to a formal marketing authorization application,” the company said.
The news comes as the U.S. government buys 614,000 additional doses of Lilly’s COVID-19 antibody therapy for $1.29 billion, which follows the purchase of 388,000 doses in September, when infections surged due to the fast-spreading Delta variant.
At the time of the withdrawal from Lilly, the EMA had received laboratory and clinical data on the quality and manufacturing process of the antibodies and the risk management plan, the EU regulator said.
The EMA had initiated a rolling review of Lilly’s antibodies, bamlanivimab and etesemivab, in March. They belong to a class of drugs called monoclonal antibodies (MABs), which mimic the body’s natural antibodies to fight off infection.
Other MABs under review by the EMA include AstraZeneca’s antibody cocktail Evusheld and GSK-Vir’s Xevudy.
(Reporting by Pushkala Aripaka in Bengaluru; Editing by Anil D’Silva and Krishna Chandra Eluri)
