FDA Approves Monoclonal Antibodies for COVID-19 Treatment for adults and children aged 12 and over
The US Food and Drug Administration (FDA) has approved the emergency use of monoclonal antibodies (mAb) bamlanivimab and etesevimab produced by pharmaceutical company Eli Lilly.
The approved combinations are indicated for the treatment of mild to moderately severe COVID-19 in children aged 12 years and over, including adults over 65 years of age, and persons with chronic diseases.
Monoclonal antibodies are lab-derived proteins that mimic the immune system’s own ability to fight harmful pathogens such as viruses. Bamlanivimab and etesevimab are mAbs that specifically target the spike proteins on SARS-CoV-2 and are designed to block the virus from attaching and entering human cells.
The FDA reports that the safety and effectiveness assessment of this experimental therapy continues. The emergency use decision is based on clinical trial data from patients at high risk of COVID-19 disease progression. The preliminary results showed that a single intravenous infusion of both bamlanivimab and etesevimab reduced hospitalisations and deaths by 70% during the 29-day observation compared to a placebo treatment.
Of the 1,035 non-hospitalised adults with mild or moderate symptoms of COVID-19, 518 received a single 2,800 milligram infusion of bamlanivimab and etesevimab and 517 received a placebo. The primary endpoint was hospitalisation due to COVID-19, or death within 29 days of surveillance. Hospitalisation, or death, occurred in 36 (7%) patients receiving placebo, compared to 11 (2%) patients treated with mAbs.
Bamlanivimab and etesevimab treatment is currently not permitted for patients already hospitalised, or receiving oxygen therapy, due to COVID-19.
The FDA issued first emergency authorisation for Pfizer and BioNTech COVID-19 vaccine in December 2020.