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EMA starts rolling review of Lilly’s COVID-19 antibodies

CHMP will review the combination of bamlanivimab and etesemivab as well as bamlanivimab monotherapy

The European Medicines Agency (EMA) has announced that its Committee for Medicinal Products for Human Use (CHMP) has launched a rolling review for Eli Lilly’s COVID-19 antibodies bamlanivimab and etesemivab.

The CHMP’s review will assess data on the antibodies used in combination for the treatment of COVID-19, and also will review bamlanivimab monotherapy.

The initiation of the rolling review is based on preliminary results from two studies – one evaluating the combination of the two antibodies and another looking at the use of bamlanivimab alone for the treatment of COVID-19.

In Lilly’s combination study – 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 of 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.

In the US, bamlanivimab received an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the treatment of mild-to-moderate COVID-19 in November 2020.

Bamlanivimab’s EUA is based on an interim analysis from the phase 2 BLAZE-1 clinical trial of 465 non-hospitalised adults with mild-to-moderate COVID-19 symptoms.

The trial’s primary endpoint was a change in viral load from baseline to day 11 for bamlanivimab versus placebo – most patients, including those on placebo, cleared the virus by day 11.

However, for patients with a high risk of disease progression, hospitalisation and accident and emergency (A&E) visits occurred in 3% of bamlanivimab-treated patients compared to 10% of placebo-treated patients.

The effects on viral load, reductions in hospitalisations and A&E visits and safety were similar across all three bamlanivimab doses tested – 700mg, 2,800mg and 7,000mg.

Earlier this week, the EMA issued advice recommending the use of Lilly’s antibody combination and bamlanivimab monotherapy for 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.

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

With regards to a formal marketing authorisation, the EMA said it will evaluate all data on the antibodies, including evidence from clinical trials, as it becomes available.

The review will continue until enough evidence is available to support the marketing authorisation for bamlanivimab and etesemivab in COVID-19, the EMA said in a statement.

Article by
Lucy Parsons

11th March 2021

From: Regulatory

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