Please login to the form below

Not currently logged in

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



Subscribe to our email news alerts

Featured jobs


Add my company
Market Access Transformation

Founded in 201, Market Access Transformation (MAT) specializes in developing agile technology platforms that enable the healthcare community to exchange...

Latest intelligence

Box 1
Strategic commitment
KOL Ambassador Program & Podcast Creation: A Customer Story
Animation: Living With
The journey from the patient's perspective...