– Reduce hospitalizations and deaths in patients at high risk of severe illness
By Molly Walker
Two monoclonal antibodies administered together, bamlanivimab and etesevimab, received emergency use authorization (EUA) for patients with mild to moderate COVID-19 at risk of severe disease, the FDA said Tuesday night .
The treatment was authorized for adult and pediatric patients, including those over 65 with chronic medical conditions, the agency said.
They specified that the combination is not authorized for hospitalized COVID-19 patients or those requiring oxygen therapy due to the disease, as it has not been studied in this population and may be associated with worse outcomes when administered to patients requiring high oxygen flow or mechanical ventilation.
"The data supporting this emergency authorization adds to the emerging evidence pointing 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.
The FDA cited data from a randomized trial of 1,035 non-hospitalized adults with mild to moderate COVID-19 at high risk of progressing to severe illness, where 518 received a single infusion of 2,800 mg of bamlanivimab and etesevimab each, and 517 received a placebo. The primary endpoint of hospitalization or death due to COVID-19 during 29 days of follow-up occurred in 2% of the intervention group versus 7% of those receiving placebo, with all 10 deaths occurring in the placebo group.
However, according to the EUA, the authorized dose is 700 mg of bamlanivimab and 1,400 mg of etesevimab, as the FDA says it is expected to have similar clinical and virological effects to the 2,800 mg dose administered together.
In November, bamlanivimab monotherapy was authorized under an EUA for patients with mild to moderate COVID-19 at risk of progressing to severe disease, although the manufacturer, Eli Lilly, anticipated the results of the combination in an October press release and peer-reviewed data on the two antibodies from the BLAZE-1 trial were published in January.
The FDA noted that serious adverse events, including hypersensitivity, anaphylaxis, and infusion site reactions, have been observed with bamlanivimab both with and without co-administration of etesevimab. Other side effects of both treatments administered together include nausea, dizziness, itching, and rash.
From: https://www.medpagetoday.com/infectiousdisease/covid19/91136