Eli Lilly to make bebtelovimab commercially available to US states from August

Eli Lilly

Eli Lilly has made plans to make its COVID-19 antibody drug, bebtelovimab, commercially available to US states, as well as hospitals and other healthcare providers from August, the company announced.

The company said it would make bebtelovimab commercially available through a sole distributor beginning the week of 15 August, ahead of the anticipated depletion of the US government’s currently available supply.

The company announced in June that it would supply the US government with an additional 150,000 doses of bebtelovimab for approximately $275m. The delivery of doses, which began immediately, was expected to meet demand until late August, the company said.

Bebtelovimab has not been approved, but has been given an Emergency Use Authorization (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 hospitalization or death, and not be able to access alternative COVID-19 treatment options approved or authorized 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 neutralizing 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 neutralization against all known variants of interest and concern.

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

The approval follows placebo-controlled, double-blind, randomized 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 hospitalized with severe COVID-19.

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