Eli Lilly and Company is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. This donation furthers both Lilly and Direct Relief's charitable goal of providing access to COVID-19 treatments to patients in need by providing these medicines free of charge to low- and lower-middle-income countries. Lilly will donate both baricitinib (4 mg tablet) as well as bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together - providing options to treat COVID-19 patients at different stages of the disease.
Direct Relief will allocate donations of baricitinib to low- and lower-middle-income countries (based on World Bank classification) for the treatment of hospitalized COVID-19 patients requiring supplemental oxygen, based on requests from these governments to Direct Relief. Donations of bamlanivimab and etesevimab together will be provided by Direct Relief to those countries for the treatment of mild to moderate COVID-19 patients at high risk of progressing to hospitalization or death in the outpatient setting.
"Direct Relief is deeply grateful for Lilly's decision to make its COVID-19 therapies available at no charge for people who otherwise would not have access to them. This is a wonderful example of each of us doing whatever we can to get through this pandemic," said Direct Relief president and CEO Thomas Tighe. "Lilly's action provides both important new options and potential resources for countries' health and regulatory leaders to consider for the care of COVID-19 patients, and Direct Relief will of course move with urgency upon receiving any such requests."
"Even as the world makes progress on vaccine roll-outs, it remains vital for treatments to be available that can make a meaningful difference for those fighting COVID-19," said David A. Ricks, Lilly chairman and CEO. "Both baricitinib as well as bamlanivimab with etesevimab together have saved the lives of COVID-19 patients at different stages of the disease. Bamlanivimab with etesevimab together reduces the risk of hospitalizations and death for high-risk patients in the outpatient setting, while recent data show baricitinib in addition to current standard of care reduces death in hospitalized patients."
The allocation of therapies will be based on the disease burden and hospitalization rates in each country. This initiative, which will commence immediately, subject to relevant local regulatory requirements, currently goes through December 2021 and will be continuously assessed based on the pandemic situation in these countries.
Ricks continued, "Today's announcement with Direct Relief will help ensure access to Lilly's COVID-19 therapies for patients around the world—no matter where they live."
The arrangement is part of Lilly's philanthropic efforts and supports Lilly 30x30, the company's goal to improve access to quality health care for 30 million people living in settings with limited resources, each year, by 2030.
Authorized Use Under the EUA and Important Safety Information for baricitinib (in the United States) for COVID-19
Baricitinib is authorized for use under an Emergency Use Authorization (EUA) in combination with remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients 2 years of age or older, requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA. Baricitinib is authorized under an EUA only for the duration of the declaration that circumstances exist justifying the authorization of the EUA of baricitinib under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
For information on the authorized use of baricitinib and mandatory requirements under the EUA, please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (Englis...
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