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EMA recommends use of Lilly’s COVID-19 antibody cocktail

Agency concludes bamlanivimab and etesevimab can be used to treat certain COVID-19 patients

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued advice recommending the use of Eli Lilly’s antibody cocktail in certain patients with COVID-19.

After completing its review of the monoclonal antibodies, the CHMP has advised that bamlanivimab and etesevimab can be used together to treat confirmed COVID-19 in high-risk patients who do not require supplemental oxygen.

The CHMP also recommended that bamlanivimab can be used as a monotherapy for the treatment of the same patients.

In the phase 3 BLAZE-1 trial, results showed that a combination of bamlanivimab and etesevimab significantly reduced the risk of hospitalisations and death in high-risk COVID-19 patients.

Across the 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.

The antibody combination treatment also demonstrated significant improvements in all key secondary endpoints, with strong evidence that the therapy reduced viral load and accelerated symptom resolution, according to Lilly.

Bamlanivimab monotherapy has also demonstrated positive trial results, having reduced viral load and symptoms, as well as COVID-19 hospitalisations by around 70%, in Lilly’s BLAZE-1 clinical programme.

The CHMP opinion can be used by EU member states to make decision of the use of the antibodies at a national level, prior to the publication of a formal marketing authorisation.

"[The] CHMP recommendation is another important milestone in our efforts to extend access to antibody therapies for patients with COVID-19 around the world, providing a pathway for more EU countries to enable use of potentially life-saving treatments for COVID-19,”  said David Ricks, chairman and chief executive officer of Lilly.

In February, the US Food and Drug Administration (FDA) issued an emergency use authorisation (EUA) for bamlanivimab plus etesevimab to treat high-risk COVID-19 patients with mild-to-moderate disease.

The antibody combination is administered together via a single intravenous infusion, which should be given as soon as possible following a positive COVID-19 test and within ten days of symptom onset.

The FDA has authorised infusion times for both bamlanivimab alone and bamlanivimab plus etesevimab as 16 or 21 minutes, respectively.

Previously, the FDA had authorised an infusion time of 60 minutes for bamlanivimab alone when it issued an EUA for the monoclonal antibody as a monotherapy in November 2020.

Article by
Lucy Parsons

8th March 2021

From: Regulatory

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