The emergency use authorization, which was issued to Eli Lilly, grants the use of bamlanivimab in combination with etesevimab for mild-to-moderate COVID-19 infection in adult and pediatric patients.
Officials with the FDA have issued an emergency use authorization (EUA) to Eli Lilly for the combination treatment of bamlanivimab and etesevimab for mild-to-moderate coronavirus disease 2019 (COVID-19) in adult and pediatric patients at high risk for severe infection.1
The authorization includes adults and pediatric patients 12 years of age and older that weigh at least 88 pounds and have tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); individuals 65 years of age and older and those with chronic medical conditions who are infected with the virus can also be treated with the drug combination.
However, the EUA is not to be applied in the hospital setting, as the bamlanivimab-etesevimab treatment has not been studied in hospitalized COVID-19 patients, including those requiring oxygen therapy. Lilly ended its trial investigating bamlanivimab in patients hospitalized with COVID-19 in November 2020 after the therapy showed worse clinical outcomes in patients requiring high flow oxygen or mechanical ventilation, according to the FDA.
The EUA is not the first for Lilly; the FDA previously authorized bamlanivimab (LY-CoV555) 700 mg for the treatment of recently diagnosed, mild-to-moderate SARS-CoV-2 infection.
Bamlanivimab is a recombinant, neutralizing human immunoglobulin G 1 monoclonal antibody (mAb) that has not been approved for any use in the US. Etesevimab is a recombinant fully human mAb that also binds to different but overlapping sites on the SARS-CoV-2 surface spike protein. The treatment should be administered together through a single intravenous (IV) infusion as soon as possible following a positive COVID-19 test and within 10 days of noticeable symptoms.2
The EUA designation was based on Lilly’s phase 3 BLAZE-1 trial, which included 1035 non-hospitalized adults with mild-to-moderate COVID-19 infection at high risk for severe manifestations of the virus, 518 of whom received a single infusion of bamlanivimab 2800 mg and etesevimab 2800 mg together. Two percent (11) of patients in the treatment group were either hospitalized or died compared with 7% (36) in the placebo group, which demonstrated a 70% reduction in hospitalizations or death. All 10 deaths were from the placebo group, and all-cause death was significantly lower in the treatment group, according to the FDA.
The agency urged health care providers to review the fact sheet on the use of bamlanivimab-etesevimab combination treatment, and has also recommended offering a fact sheet for patients, parents, and caregivers.
Daniel Skovronsky, MD, PhD, chief scientific officer at Eli Lilly and president of Lilly Research Laboratories, is hopeful that the monoclonal antibodies will continue to have benefit amid the COVID-19 pandemic response.2 "Bamlanivimab alone under emergency use authorization has already provided many people with an early treatment option that could prevent hospitalizations and we are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit,” Skovronsky said. “Additionally, with the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world," he added.2