The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Lilly’s severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibodies bamlanivimab plus etesevimab for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in patients 12 years of age and older weighing at least 40kg who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Under the EUA, bamlanivimab and etesevimab should be administered together via a single intravenous (IV) infusion immediately after a positive COVID-19 test and within 10 days of symptom onset. The combination therapy is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
The EUA was granted based on data from the randomized, double-blind, placebo-controlled phase 3 BLAZE-1 trial (ClinicalTrials.gov: NCT04427501), which assessed bamlanivimab plus etesevimab in 1035 non-hospitalized adults with mild to moderate COVID-19 symptoms. Patients were randomly assigned 1:1 to receive a single IV infusion of bamlanivimab 2800mg plus etesevimab 2800mg (n=518) or placebo (n=517). The primary end point was COVID-19 related hospitalizations or death by any cause during 29 days of follow-up.
Findings showed the combination therapy reduced the risk of hospitalization or death (known as an “event”) by 70% (P =.0004); among 1035 patients, there were 11 events (2.1%) in the bamlanivimab plus etesevimab group and 36 events (7.0%) in the placebo group. As for safety, the most common adverse event reported was nausea. There were 10 deaths in the study, all of which occurred in the placebo group.
Based on an analysis of available data, the authorized dosage for the combination therapy is 700mg of bamlanivimab and 1400mg of etesevimab administered together; this regimen is expected to have similar clinical effects as the 2800mg dosages evaluated in the study.
“The data supporting this emergency authorization add to emerging evidence that points to the clinical utility of neutralizing antibodies for the treatment of COVID-19 in certain patients,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research.
On November 2020, the FDA issued an EUA for bamlanivimab monotherapy for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
“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,” said Daniel Skovronsky, MD, PhD, Lilly’s chief scientific officer and president of Lilly Research Laboratories. “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.”
The FDA also authorized a shortened infusion time of 16 minutes for bamlanivimab alone and 21 minutes for bamlanivimab plus etesevimab together; the previously authorized infusion time was 60 minutes.
The health care provider fact sheet for the combination therapy can be found here.
- Coronavirus (COVID-19) update: FDA authorizes monoclonal antibodies for treatment of COVID-19. [press release]. Silver Springs, MD: US Food and Drug Administration; February 9, 2021.
- Lilly’s bamlanivimab (LY-CoV555) administered with etesevimab (LY-CoV016) receives FDA emergency use authorization for COVID-19. [press release]. Indianapolis, IN: Eli Lilly and Company; February 9, 2021.