The U.S. FDAhas expanded the Emergency Use Authorization (EUA) for bamlanivimab 700 mg and etesevimab 1400 mg administered together to include post-exposure prophylaxis (PEP) in certain individuals for the prevention of SARS-CoV-2 infection, Eli Lilly and Company (NYSE: LLY) announced today. The neutralizing antibodies can now be used together to treat high-risk individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination, and have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in an institutional setting, including a nursing home or prison. This authorization follows the national reopening of distribution earlier this month.
“Despite very significant improvements to public health resulting from COVID-19 vaccination, with the rise of the highly contagious Delta variant, the virus continues to have a devastating impact on the most vulnerable individuals, including nursing home residents and individuals with medical conditions that put them at high risk for the most severe outcomes,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories. “We’re pleased that this expansion will help us provide antibody therapies as post-exposure prophylaxis to help prevent the spread of COVID-19 to some of the most at-risk individuals in the U.S.”
The expanded authorization is based on data from BLAZE-2, a study conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN), that enrolled residents and staff at long-term care facilities, commonly referred to as nursing homes, across the U.S. In this placebo-controlled Phase 3 study, bamlanivimab 4200 mg reduced the risk of contracting symptomatic COVID-19 by up to 80 percent in nursing home residents and up to 57 percent among residents and staff of long-term care facilities.
“Recent reports suggest that fully vaccinated residents of nursing homes have contracted COVID-19, some of whom became quite ill,” said Myron Cohen, M.D., director of UNC’s Institute for Global Health and Infectious Diseases and a CoVPN leader. “This additional emergency use authorization of monoclonal antibodies for post-exposure prophylaxis in addition to the treatment of COVID-19 offers a significant achievement in the fight against this pandemic.”
Since the beginning of the pandemic, Lilly has mobilized the company’s scientific and medical expertise to fight this terrible disease. Lilly’s bamlanivimab was the first neutralizing monoclonal antibody to be granted emergency use authorization from the FDA as a treatment for mild to moderate COVID-19 — providing a valuable therapy at a time in the U.S. when cases were increasing to their highest level. Lilly now only supplies bamlanivimab and etesevimab together in the U.S.
“In just months, Lilly achieved what usually takes years by bringing multiple therapies to patients under emergency use authorizations,” continued Skovronsky. “Since then, over 535,000 treatment courses of bamlanivimab or bamlanivimab and etesevimab together have been administered to patients, potentially preventing more than 25,000 hospitalizations and 10,000 deaths during the worst of the pandemic in the U.S.”
Pseudovirus and authentic virus studies demonstrate that bamlanivimab and etesevimab together retain neutralization activity against the Alpha and Delta variants. On September 2nd, the Office of the Assistant Secretary for Preparedness and Response (ASPR), alongside the U.S. Food and Drug Administration (FDA), resumed the shipment and distribution of bamlanivimab and etesevimab administered together.
For more information about the use of bamlanivimab and etesevimab together for the treatment of mild to moderate COVID-19 and prevention of COVID-19 in high-risk patients under the FDA’s emergency use authorization, please see the Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers (English) (Spanish), click here or contact Lilly’s 24-hour support line at 1-855-LillyC19 (1-855-545-5921). Patients and physicians can visit the NICA Infusion Center Locator or the HHS Therapeutics Distribution locator to find a potential therapy location.
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.