| Post date: 2021/02/22 |
Monoclonal antibodies (mAbs) are laboratory-made proteins with the ability of human antibody mimicry in the immune system. MAbs have been able to fight off harmful pathogens such as cancer cells and viruses.
After being effective in cancer, mAbs against COVID-19 are gaining momentum. Bamlanivimab and etesevimab together have been effective against the spike protein of SARS-CoV-2. The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab, administered together, for the treatment of mild to moderate COVID-19 in adults and pediatric patients. The data supporting this EUA for bamlanivimab and etesevimab are based on positive results from a Phase III trial that showed bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%.
This randomized, double-blind, placebo-controlled clinical trial was conducted in 1,035 non-hospitalized adults with mild to moderate COVID-19 symptoms who were at high risk for progressing to severe COVID-19. 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.
Adopted and extracted from http://www.fda.gov
After being effective in cancer, mAbs against COVID-19 are gaining momentum. Bamlanivimab and etesevimab together have been effective against the spike protein of SARS-CoV-2. The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab, administered together, for the treatment of mild to moderate COVID-19 in adults and pediatric patients. The data supporting this EUA for bamlanivimab and etesevimab are based on positive results from a Phase III trial that showed bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%.
This randomized, double-blind, placebo-controlled clinical trial was conducted in 1,035 non-hospitalized adults with mild to moderate COVID-19 symptoms who were at high risk for progressing to severe COVID-19. 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.
Adopted and extracted from http://www.fda.gov
Keywords: monoclonal-antibodies | COVID-19 | bamlanivimab | etesevimab |
View: 2498 Time(s) |
Print: 408 Time(s) |
Email: 0 Time(s) |
0 Comment(s)
