Lilly submitted a request for an EUA for bamlanivimab for the treatment of mild to moderate COVID-19 in high-risk patients to the FDA in early October. The initial agreement is for delivery over the two months following an EUA and also provides the option for the U.S. government to purchase up to an additional 650,000 vials through June 30, 2021, under the same terms as the base agreement and subject to agreement from Lilly, product availability and the medical need in the U.S.
“Lilly has leveraged our deep scientific capability to fight this pandemic and we are proud of our efforts to develop potential medicines to combat COVID-19. Supply agreements with governments – such as this one with the U.S. government to meet Operation Warp Speed goals – are fundamental to enable the most widespread and equitable access to our potential therapy,” said David Ricks, Lilly’s chairman and CEO. “The U.S. is experiencing a surge in COVID-19 cases and associated hospitalizations, and we believe bamlanivimab could be an important therapeutic option that can bring value to the overall healthcare system, as it has shown a potential benefit in clinical outcomes with a reduction in viral load and rates of symptoms and hospitalizations.”
If an EUA is granted, the U.S. government has committed that patients will have no out-of-pocket costs for the medicine, although healthcare facilities may charge a fee for the product’s administration. The federal government, in partnership with state health departments, is developing a government allocation program for bamlanivimab. As part of this government program, Lilly is partnering with Operation Warp Speed and a national distributor to finalize distribution plans and shipping preparations, should an EUA be granted. The intravenous administration of therapeutics to patients with confirmed mild to moderate COVID-19 presents unique challenges to the healthcare system. Lilly is also working closely with Operation Warp Speed to assist U.S.federal and state agencies in the identification and creation of options for locations where patients can receive this medication that are accessible and minimize infection transmission.
Lilly anticipates manufacturing up to one million doses of bamlanivimab 700 mg by the end of 2020 – with 100,000 doses ready to ship within days of authorization – for use around the world. The supply of Lilly’s antibody therapy is expected to increase substantially beginning in Q1 2021, as additional manufacturing resources come online throughout the year. Lilly has a robust, global supply chain in place to produce bamlanivimab, with five active pharmaceutical ingredients (API) manufacturing sites worldwide. To ensure rapid access of this treatment to patients around the world, Lilly has invested in large-scale manufacturing of bamlanivimab at risk – even before data demonstrated its potential to become a meaningful therapeutic option for COVID-19.
Discussions with global regulators are ongoing. Global allocation will be made based on Lilly’s guiding principles that aim to ensure access for patients with high unmet need, no matter where they live. Read more about Lilly’s global pricing and access principles for its antibody therapies at lilly.com.
“We are also partnering with governments and philanthropic organizations around the world to ensure a fair and transparent allocation of the limited supply of our antibody therapies to those who need it most, based on a global methodology using data from trusted research centers,” Ricks continued.