COVID-19: FDA advisory committee needed before more EUAs for monoclonals

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Press release claims benefit in nursing home COVID prevention study

By Daniel R. Lucey MD, MPH, FIDSA

 In a press release today Lilly reported that its neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80% for residents”.  The release states that the intravenous dose used was “4,200 mg of bamlanivimab” or placebo.

Unlike the situation in Nov. 2020, under the former U.S. Food and Drug Administration commissioner Dr. Stephen Hahn, if Lilly requests emergency use authorization for this monoclonal antibody for the specific indication of prevention, rather than early treatment of non-hospitalized patients, then the FDA should convene an open independent advisory committee to advise on the EUA.

Today’s press release also stated: “Bamlanivimab 700 mg injection is authorized for use under EUA for treatment of mild to moderate 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 progressing to severe COVID-19 and/or hospitalization”

Of note, concerns were raised here Oct.29, 2020 about the need for an FDA advisory committee before this EUA was granted Nov. 9, 2020. No FDA advisory committee was convened, however, before this EUA was granted, the first-ever for a monoclonal antibody against an infectious disease pathogen.

Not surprisingly, clinicians’ use of this monoclonal antibody under the indications specified Nov. 9, 2020 have been lower than anticipated.

Dr. Daniel Lucey

Daniel Lucey, M.D. MPH, FIDSA, FACP, Clinical Professor of Medicine at Dartmouth Geisel School of Medicine, Infectious Disease adjunct Professor at Georgetown Medical Center, senior scholar at Georgetown Law, Anthropology Research Associate at the Smithsonian Museum of Natural History and a member of the Infectious Diseases Society of America Global Health Committee. He served as a volunteer to outbreaks overseas including hands-on Ebola patient care in Sierra Leone and Liberia (Doctors without Borders) 2014, MERS 2013, SARS 2003, as well as HIV, H5N1, Zika, yellow Fever, and pneumonic plague 2017 (with WHO/USAID/CDC).  Since Jan. 6, 2020 he has contributed over 75 posts to Science Speaks on COVID-19 and traveled to China in February 2020. He initially proposed, then fundraised and helped design the content for 2018-2022 Smithsonian Exhibition on Epidemics due to zoonotic viruses. From 1982-1988 he trained at University of California San Francisco and Harvard and was an attending physician at the NIH (NIAID) in the 1990s while in the US Public Health Service.

 

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