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EMA launches rolling review of Regeneron’s COVID-19 antibody cocktail

Study suggests REGN-COV2 can reduce viral load in non-hospitalised patients with COVID-19

The European Medicines Agency (EMA) has started a rolling review of Regeneron’s monoclonal antibody cocktail REGN-COV2 for the treatment and prevention of COVID-19.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) will review the preliminary results from a study that suggests REGN-COV2 (casirivimab/imdevimab) can reduce the viral load in non-hospitalised patients with COVID-19.

Although the EMA has started the rolling review, it added in a statement that it has not yet evaluated the full study, so cannot yet draw any conclusions regarding the benefit-risk ratio of REGN-COV2.

However, the EMA has already started evaluating data from laboratory and animal studies of the antibody cocktail.

"The CHMP will evaluate all data on this medicine, including evidence from a study [of REGN-COV2] in hospitalised patients with COVID-19 and other clinical trials as they become available," the EMA said in a statement.

"The rolling review will continue until enough evidence is available to support a formal marketing authorisation application," the agency added.

Last week, Regeneron announced results from the first 400 evaluable participants in its ongoing phase 3 trial, which is evaluating the cocktail for the prevention of COVID-19 in high-risk populations.

The first exploratory analysis found that passive vaccination with REGN-COV2 resulted in 100% prevention of symptomatic COVID-19 infections.

On top of that, the cocktail led to approximately 50% lower overall rates of infection – with infections occurring with REGN-COV2 therapy all being asymptomatic.

Regeneron added that the infections observed in the placebo group had more than 100-fold higher peak viral loads compared to patients treated with its antibodies.

Another antibody combination treatment, developed by Eli Lilly, also recently produced promising results in high-risk COVID-19 patients.

In the phase 3 BLAZE-1 trial,  bamlanivimab 2800mg was administered alongside estesevimab 2800mg in high-risk patients who had recently been diagnosed with COVID-19.

The study met its primary endpoint, achieving a significant reduction in COVID-19-related hospitalisations and deaths in high-risk COVID-19 patients.

Across the entire study population, which included 1,035 patients, there were 11 events in patients receiving Lilly’s antibody combination treatment, while 36 events occurred in the placebo group.

This represented a 70% risk reduction, with no deaths occurring in the bamlanivimab and etesevimab-treated group.

Article by
Lucy Parsons

2nd February 2021

From: Regulatory



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