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(Adds details on U.S. status, EU purchases and priorities)
By Pushkala Aripaka and Ludwig Burger
Nov 2 (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)
