Bamlanivimab - Eli Lilly new monoclonal antibody LY-555 for treatment of COVID-19

This is a complete new drug review of bamlanivimab, a monoclonal antibody used to treat COVID-19 or the coronavirus. A visual explanation of the drug’s unique mechanism of action of binding to the spike protein of the virus and neutralizing it will be presented. The restrictions placed on this new drug due to its emergency use authorization (EUA) will be outlined. Results of he Blaze-1 study will be discussed and evaluated to determine how effective bamlanivimab is against Covid-19. Covered topics include mixing instructions, precautions, and adverse drug reactions. This is a concise review that hopefully will provide the healthcare professional with useful information. BAMLANIVIMAB Additional News and Links: *** IMPORTANT NEWS: December 23, 2021 ASPR and the FDA released a joint statement on the circulating SARS-CoV-2 viral variants, including Omicron, and how the variants may be associated with resistance to monoclonal antibodies. Data show that it is unlikely that bamlanivimab and etesevimab administered together or REGEN-COV will retain activity against this variant. Based on this information, ASPR will pause any further allocations of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV pending updated data from the CDC. https://www.fda.gov/news-events/press... April 16, 2021: The FDA is no longer recommending that bamlanivimab be administered by itself due to a sustained increase in COVID-19 variants that are resistant to bamlanivimab which resulted in treatment failure. Healthcare facilities and providers may only administer the combination of bamlanivimab together with etesevimab consistent with the terms and conditions of the EUA seen in the following link: http://pi.lilly.com/eua/bam-and-ete-e... Bamlanivimab and etesevimab bind to different but overlapping epitopes in the receptor binding domain (RBD) of the S-protein. Using both antibodies together is expected to reduce the risk of viral resistance. --------------------------------------------------------------------------------------------- January 21, 2021: Final analyses of the BLAZE-1 trial published on-line in JAMA. Combination treatment using a higher dose of bamlanivimab 2800 mg combined with etesevimab (another monoclonal neutralizing antibody) resulted in a statistically significant reduction in viral load at Day #11 compared to placebo. https://jamanetwork.com/journals/jama... 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. --------------------------------------------------------------------------------------------- December 22, 2020: New England Journal published study of ACTIV-3/TICO Trial. Monoclonal antibody Bamlanivimab, when coadministered with remdesivir, did not demonstrate efficacy among hospitalized patients who had Covid-19 without end-organ failure. https://www.nejm.org/doi/10.1056/NEJM... Nov 21, 2020: FDA's emergency use authorization (EUA) for monoclonal antibodies given to President Trump: casirivimab and imdevimab, manufactured by Regeneron. . https://www.fda.gov/news-events/press... Healthcare professionals only: https://www.fda.gov/media/143892/down... ----------------------------------------------------------------------------------------------------------------------------- Fact sheet for Healthcare Providers http://pi.lilly.com/eua/bamlanivimab-... Fact sheet for Patients, Parents, and Caregivers http://pi.lilly.com/eua/bamlanivimab-... BLAZE-1 Study https://www.nejm.org/doi/full/10.1056... To find out how much bamlanivimab has been allocated to specific states, territories, and jurisdictions, visit: https://www.phe.gov/emergency/events/... FDA MedWatch Form link to report ADRs: www.fda.gov/medwatch/report.htm Eli Lilly adresses to provide a copy of the FDA MedWatch form Fax: 1-317-277-0853 E-mail: [email protected]