By Pushkala Aripaka and Ludwig Burger
(Reuters) -Eli Lilly has retracted a request for European Union approval of its antibody-based treatment for COVID-19, citing a lack of demand from EU member states as the bloc focuses on other suppliers.
The European Medicines Agency (EMA) said on Tuesday it had ended its rolling review of a cocktail of two monoclonal antibodies known as etesevimab and bamlanivimab after the U.S.-based drugmaker withdrew from the process https://www.ema.europa.eu/en/news/ema-ends-rolling-review-antibodies-bamlanivimab-etesevimab-covid-19-following-withdrawal-lilly.
Lilly’s letter https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-bamlanivimab-etesevimab_.pdf to the regulator, 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 on the day that the U.S. government agreed to buy 614,000 additional doses of Lilly’s antibody combo for $1.29 billion, which follows the purchase of 388,000 doses of etesevimab in September to supplement stocks of bamlanivimab it had previously bought.
The United States had already given emergency approval for the drug cocktail for patients at an early stage of the disease to prevent deterioration and for some people who have been exposed to the virus.
Even though the EU in September procured 220,000 courses of bamlanivimab and etesevimab, contingent on approval, the EU Commission in mid-October omitted the combination from a list https://ec.europa.eu/commission/presscorner/detail/en/IP_21_5366 of 10 treatments most promising for COVID-19.
The EU in March signed a deal with Roche for an antibody cocktail developed with Regeneron, and in July struck another deal for GlaxoSmithKline and Vir’s antibody drug.
At the time of Lilly’s withdrawal, 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 in March. They belong to a class of drugs called monoclonal antibodies (MABs), which are lab-made versions of the body’s natural antibodies to fight off infection.
The European regulator continues to review other virus-fighting MABs being developed by Regeneron and Roche, the GlaxoSmithKline and Vir alliance, as well as AstraZeneca and South Korea’s Celltrion.
(Reporting by Pushkala Aripaka in Bengaluru, Ludwig Burger in Frankfurt and Francesco Guarascio in Brussels; Editing by Anil D’Silva, Krishna Chandra Eluri and Catherine Evans)
