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Eli Lilly to supply US government with 150,000 additional doses of bebtelovimab

The antibody drug treatment has thus far only been authorised for emergency use by the FDA to treat COVID-19 in specific emergency cases in non-hospital settings

Eli Lilly

Eli Lilly (Lilly) has announced it will supply the US government with an additional 150,000 doses of bebtelovimab, an antibody to treat the COVID-19 Omicron variant, for approximately $275m.

The delivery of doses will begin immediately and, along with the US government’s existing supply of bebtelovimab, is expected to meet present demand until late August, the company said.

Bebtelovimab has not been approved, but has been given an Emergency Use Authorisation (EUA) by the US Food and Drug Administration (FDA) for the treatment of adults with mild-to-moderate COVID-19, and children aged 12 or older, in specific emergency cases in non-hospital settings.

Patients must have had a positive SARS-CoV-2 viral test and be at high risk of developing severe COVID-19 that could lead to hospitalisation or death, and not be able to access alternative COVID-19 treatment options approved or authorised by the FDA.

The EUA was based on the results from Lilly’s phase 2 BLAZE-4 clinical trial which demonstrated that bebtelovimab retained full neutralising activity against Omicron, the current predominant strain of COVID-19 in the US, and all other known variants of concern. According to the company, Bebtelovimab continues to maintain neutralisation against all known variants of interest and concern.

Commenting on the agreement, David Ricks, Lilly’s chair and CEO, said: "Lilly and its collaborators have partnered closely with the federal government throughout the pandemic to ensure broad and equitable access to our monoclonal antibodies.

"While congress works toward additional COVID-19 funding, Lilly and the US government will continue to work together to support the availability of bebtelovimab to maximise equity and accessibility in the US market."

In May, Eli Lilly and Incyte were granted FDA approval for their COVID-19 therapy Olumiant (baricitinib) for the treatment of hospitalised adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation.

The approval followes placebo-controlled, double-blind, randomised trials and involves a recommended dose of 4mg once daily for 14 days or until final hospital discharge, whichever comes first.

A trial led by The University of Oxford also demonstrated that baricitinib, an anti-inflammatory treatment usually used to treat rheumatoid arthritis, improved survival rate when given to patients who have been hospitalised with severe COVID-19.

Article by
Emily Kimber

30th June 2022

From: Healthcare

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