WASHINGTON —The FDA issued an emergency use authorization (EUA) for combination bamlanivimab/etesevimab to treat individuals age 12 and older with mild-to-moderate Covid-19 who are at high risk for progressing to severe disease.
While this EUA does not authorize bamlanivimab/etesevimab to treat hospitalized Covid-19 patients or those who require oxygen therapy, the current indication does include treatment for patients with mild or moderate disease who are 65 years of age or older and those with chronic medical conditions, the FDA explained.
“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,” Patrizia Cavazzoni, MD, acting director of the Center for Drug Evaluation and Research at the FDA, said in a statement.
The FDA previously issued an EUA for bamlanivimab in November 2020, and another combination treatment, casirivimab/imdevimab, received authorization that same month. For the new combination treatment, the FDA set the dosage at 700 mg bamlanivimab and 1,400 mg etesevimab administered jointly, noting that available preclinical, clinical, and virologic data “support that the authorized dosage is expected to have a similar clinical and virologic effect to 2,800 milligrams bamlanivimab and 2,800 milligrams etesevimab administered together.”
This authorization is “based on a randomized, double-blind, placebo-controlled clinical trial in 1,035 non-hospitalized adults with mild to moderate Covid-19 symptoms who were at high risk for progressing to severe Covid-19,” the FDA wrote. “Of these patients, 518 received a single infusion of bamlanivimab 2,800 milligrams and etesevimab 2,800 milligrams together, and 517 received placebo. The primary endpoint was Covid-19 related hospitalizations or death by any cause during 29 days of follow-up. Hospitalization or death occurred in 36 (7%) patients who received placebo compared to 11 (2%) patients treated with bamlanivimab 2,800 milligrams and etesevimab 2,800 milligrams administered together, a 70% reduction. All 10 deaths (2%) deaths occurred in the placebo group. Thus, all-cause death was significantly lower in the bamlanivimab 2,800-milligram and etesevimab 2,800-milligram group than the placebo group.”
The agency explained that, under this EUA, fact sheets will be given to health care providers and patients and caregivers to outline dosing instructions, potential side effects, and drug interactions.
“Serious and unexpected adverse events including hypersensitivity, anaphylaxis, and infusion-related reactions have been observed with bamlanivimab with and without co-administration of etesevimab,” the FDA warned. “In addition, clinical worsening following bamlanivimab administration has been reported, although it is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Possible side effects of bamlanivimab and etesevimab administered together include nausea, dizziness, pruritus, and rash.”
This EUA was issued to Eli Lilly and Co.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 190
Topic ID: 79,190,730,933,190,926,192,927,725,928,925,934
