A combination antibody infusion from drugmaker Eli Lilly has received emergency use authorization for patients including people over age 65 with chronic disease, the Food and Drug Administration announced Tuesday.
The therapy is approved for treating mild to moderate COVID-19 in patients 12 years or older at high risk for progressing to severe COVID-19 and/or hospitalization. Patients at high risk include older adults and those with a wide range of illnesses, the agency explains in a related EUA drug fact sheet.
Clinical trial data have shown that a single intravenous infusion of bamlanivimab and etesevimab given together “significantly reduced COVID-19-related hospitalization and death during 29 days of follow-up compared to placebo,” the FDA said in a statement. The two drugs should be administered together via a single intravenous infusion “as soon as possible after a positive COVID-19 test and within 10 days of symptom onset,” according to Eli Lilly.
In response to feedback from front-line nurses and doctors, the FDA also has authorized a significantly shortened infusion time for bamlanivimab alone and bamlanivimab and etesevimab together. Infusion time can now be as little as 16 or 21 minutes, respectively, as compared to the previously authorized time of 60 minutes, Eli Lilly reported.
The new FDA authorization is based on late-stage trial data that showed that bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70% in study participants.
Another clinical trial recently showed that bamlanivimab given alone reduced the risk of contracting symptomatic COVID-19 among a large cohort of long-term care residents by up to 80%.