UPDATED: EU begins review of Eli Lilly’s antibodies for COVID-19

Europe’s drug regulator said on Thursday it had initiated a rolling review of U.S.-based Eli Lilly’s antibodies to treat COVID-19, days after saying their combination could be used in patients at high risk of progressing to severe illness.

Lilly’s bamlanivimab and etesemivab belong to a class of drugs called monoclonal antibody treatments, which mimic natural antibodies the body generates to fight infection.

This is the latest antibody treatment to earn such a review in the region and follows the European Medicines Agency’s (EMA) evaluation of drugs from South Korea’s Celltrion and U.S.-based Regeneron.

The rolling reviews are aimed at speeding up the approval process by allowing researchers to submit findings in real-time before final trial data is available.

Vir Biotechnology and Britain’s GSK plan to seek emergency use authorization for their experimental antibody therapy after interim data, the companies said on Thursday.

EMA said it was yet to evaluate the full dataset, adding it was too early to draw any conclusions regarding the benefit-risk balance of Lilly’s medicines.

It said the decision to start the review was based on preliminary results from two studies, one testing the ability of the antibodies to treat patients when combined and the other when bamlanivimab is used as a standalone.

So far, vaccines from Pfizer/BioNTech,, Moderna and AstraZeneca/Oxford have been approved in the region, with the verdict on J&J’s single-shot vaccine is expected later in the day.

Earlier Eli Lilly and Co said that its combination antibody therapy to fight COVID-19 reduced the risk of hospitalization and death by 87% in a study of more than 750 high-risk COVID-19 patients.

It is the second large, late-stage study to show that combination therapy of two antibodies, bamlanivimab and etesevimab, is effective at treating mild to moderate cases of COVID-19.

The previous study, which published data in January, used a higher dose of the drugs and reduced risk of hospitalization by 70%.

“I expect this data to continue to drive more utilization” of the antibodies,” said Daniel Skovronsky, chief scientific officer at Eli Lilly.

“We have few other diseases where we have drugs that can offer this magnitude of benefit.”

U.S. regulators authorized the combination therapy in February for use in COVID-19 patients 12 and over with a high risk of developing serious complications. European regulators greenlighted its use in March.

The United States agreed in February to purchase a minimum of 100,000 doses of the combination treatment.

Regulators authorized bamlanivimab alone for use against COVID-19 last year and the U.S. government agreed to purchase nearly 1.5 million doses.

Skovronsky said the combination therapy has the benefit of offering greater protection against new strains of COVID-19.

A variant of COVID-19 originally discovered in Britain has infected patients in most U.S. states and is expected to become the country’s dominant strain.

“We are quite confident this combo covers all of the variants in the U.S.,” Skovronsky said, adding Lilly is studying an additional treatment for new COVID strains first identified in South Africa and Brazil, which have not become widespread in the United States.

Skovronsky said that Lilly is prepared to manufacture 1 million doses of the combination therapy in the coming months and is in active talks to supply governments around the world with the treatment.

Main Photo: An undated handout photo made available by the Nanographics GmbH company in Vienna, Austria, shows a high resolution render of a SARS-CoV-2 cyro-electron tomography (cryo-ET) scan. EPA-EFE/NANOGRAPHICS GMBH