The US government has purchased an additional 650,000 doses of Lilly’s neutralising COVID-19 antibody bamlanivimab, the company has announced.
Bamlanivimab scored an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) in November for the treatment of high-risk, mild-to-moderate COVID-19 patients.
The US government has paid $812.5m for the additional doses, which are set to be delivered until 31 January 2021. At least 350,000 of these additional doses are expected to be delivered in December 2020.
Following the new purchase agreement, the total number of bamlanivimab doses secured by the US government totals 950,000.
“Given the significant increase in COVID-19 cases and hospitalisations in the US, we are doing everything possible to quickly provide more bamlanivimab doses to Americans,” said David Ricks, chairman and chief executive officer of Lilly.
“We are proud of our work to deploy significant manufacturing capacity and remain committed to enabling widespread and equitable access to bamlanivimab. The US government’s efforts to allocate bamlanivimab around the country is critical to ensuring it reaches patients who need it the most,” he added.
In an interim analysis conducted from the phase 2 BLAZE-1 clinical trial, bamlanivimab cleared the novel coronavirus by day 11 in most patients with mild-to-moderate COVID-19 symptoms.
Patients with a high risk of disease progression included in this study also saw their risk of hospitalisation and hospital visits drop when treated with bamlanivimab compared to the placebo group.
Lilly has reiterated that bamlanivimab is only indicated under emergency use for patients with mild-to-moderate COVID-19 symptoms.
It is not indicated or authorised for use in patients who have been hospitalised with COVID-19, and may actually be associated with worse clinical outcomes when administered to hospitalised patients who require high flow oxygen or mechanical ventilation.
Another COVID-19 antibody cocktail, developed by Regeneron, also holds an EUA in the US for the treatment of mild-to-moderate high-risk COVID-19 patients.
As part of the US’ Operation Warp Speed initiative, Regeneron signed an agreement for the initial supply of 300,00 doses of the antibody cocktail.
Under Operation Warp Speed, both Lilly’s bamlanivimab and Regeneron’s antibody cocktail will be made available to patients at no cost – although both companies added that there may be ‘charge fees’ related to administration in healthcare settings.