The U.S. Food and Drug Administration (FDA) has 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.
| INDIANAPOLIS, Sept. 16, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has 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. For media resources, including product images and fact sheets, please click here. Important Information about bamlanivimab and etesevimab together Bamlanivimab and etesevimab together are authorized under Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and etesevimab together and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers (English) (Spanish) for bamlanivimab and etesevimab together. Authorized Use and Important Safety Information TREATMENT Bamlanivimab and etesevimab together are authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Limitations of Authorized Use: Treatment Combined Frequency of Variants Resistant to Bamlanivimab and Etesevimab
Use in Patients Who Are Hospitalized or Who Require Oxygen Due to COVID-19 Bamlanivimab and etesevimab together are not authorized for use in patients:
Treatment with bamlanivimab and etesevimab together has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. POST-EXPOSURE PROPHYLAXIS Bamlanivimab and etesevimab administered together are authorized for post-exposure prophylaxis of COVID-19 in adults and pediatric individuals (12 years of age or older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:
Limitations of Authorized Use: Post-Exposure Prophylaxis
Important Safety Information Warnings and Precautions Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions Infusion-related reactions, occurring during or up to 24 hours after infusion, have been observed with administration of bamlanivimab and etesevimab together. These reactions may be severe or life threatening. Signs and symptoms of infusion-related reactions may include:
Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of bamlanivimab and etesevimab under Emergency Use Authorization. Clinical Worsening After Receiving Bamlanivimab and Etesevimab Administration Limitations of Benefit and Potential Risk in Patients with Severe COVID-19 Adverse Reactions Use in Specific Populations Pregnancy Breastfeeding BM ET HCP EUA ISI 16SEP2021 About bamlanivimab and etesevimab Etesevimab (LY-CoV016, also known as JS016) is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS). Junshi Biosciences leads development in Greater China, while Lilly leads development in the rest of the world. Results from a Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) were published in the New England Journal of Medicine. Results from a Phase 3 study of bamlanivimab in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) were published in the Journal of American Medical Association (JAMA). A Phase 2 study assessing the efficacy and safety of bamlanivimab alone, and bamlanivimab with other neutralizing antibodies versus placebo for the treatment of symptomatic low-risk COVID-19 in the outpatient setting (BLAZE-4. NCT04634409) has completed enrollment. About Lilly’s COVID-19 Efforts About Eli Lilly and Company Lilly Cautionary Statement Regarding Forward-Looking Statements PP-BE-US-0105 09/2021 ©Lilly USA, LLC 2021. All rights reserved. i FDA will make this determination considering current variant frequency data (available at: https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proportions.html), trends in variant frequency over time, the precision of the estimates and information regarding emerging variants of concern. FDA will update the list of states, territories, and US jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized as new data and information becomes available. Healthcare providers should refer to the FDA website regularly for updates.
SOURCE Eli Lilly and Company | ||||||||
Company Codes: NYSE:LLY |
View original content to download multimedia:
