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FDA Approves Eli Lilly’s Combination COVID-19 Antibody Treatment
The combination COVID-19 antibody treatment can now be administered to adult and pediatric patients and to those who are at high risk for progressing to severe disease.
FDA recently issued an emergency use authorization to Eli Lilly & Company for its combination COVID-19 antibody treatment.
The authorization states that providers can administer the combination of bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) to infected adult and pediatric patients who are 12 years of age or older and weigh at least 88 pounds.
Additionally, those who are at high risk for progressing to severe COVID-19 and those who are over 65 years of age or who have certain chronic conditions may also receive the treatment.
The treatment is not authorized for patients who are hospitalized or require oxygen therapy due to the coronavirus. Monoclonal antibodies, such as bamlanivimab and etesevimab, may worsen clinical outcomes, FDA highlighted.
“Today’s action, which provides another treatment for COVID-19, reflects the FDA’s strong commitment to working with sponsors to expand potential treatment options health care providers can use to fight this pandemic,” Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research, said in the announcement.
In mid-November, FDA issued an emergency use authorization for a single infusion of 700 milligrams of bamlanivimab for use in mild to moderate coronavirus in adults and pediatric patients.
Under the recent emergency use authorization, 700 milligrams bamlanivimab alone, as well as 700 milligrams bamlanivimab and 1,400 milligrams etesevimab administered together, will be available.
FDA also required that fact sheets containing important information about using bamlanivimab and etesevimab together, including dosing instructions, potential side effects, and drug interactions, be made available to healthcare providers, patients, and caregivers.
The authorization was based on an analysis of available preclinical and clinical data, as well as pharmacokinetic and pharmacodynamic modeling.
For example, the agency noted a recent trial found that a single infusion of bamlanivimab and etesevimab administered together significantly reduced coronavirus-related hospitalizations and deaths during 29 days of follow-up compared to a placebo.
The safety and effectiveness of the treatment in this trial will continue to be evaluated.
“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. As part of our Coronavirus Treatment Acceleration Program, the FDA uses every resource at our disposal to make treatments such as these monoclonal antibodies available while continuing to study their safety and effectiveness,” Cavazzoni continued.
Additional positive data came from Eli Lilly & Company’s Phase 3 clinical trial of 1,035 non-hospitalized adults with mild to moderate COVID-19 symptoms.
Researchers found that 2,800 milligrams of bamlanivimab and 2,800 milligrams of etesevimab together elicited statistically significant improvement on all key secondary endpoints, reduced viral load, and boosted symptom resolution.
Across all 1,035 patients in the trial, there were only 11 adverse events in patients taking the therapy and 36 events in patients taking the placebo. Notably, the reported 10 deaths in the study all took place in the placebo group.
The data supports that the authorized dosage will have a similar clinical effect to 2,800 milligrams bamlanivimab and 2,800 milligrams etesevimab administered together, FDA stated.
"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,” Daniel Skovronsky, MD, PhD, Eli Lilly & Company’s chief scientific officer and president of Lilly research laboratories, said in a press release following the approval.
"As COVID-19 cases, hospitalizations and subsequent deaths continue to rise, we are committed to working with the U.S. government to supply our antibody therapies for use by patients across the country," Skovronsky added.
