Lilly's bamlanivimab (LY-CoV555) administered with etesevimab (LY-CoV016) receives FDA emergency use authorization for COVID-19http://lilly.mediaroom.com/2021-02-09-Lillys-bamlanivimab-LY-CoV555-administered-with-etesevimab-LY-CoV016-receives-FDA-emergency-use-authorization-for-COVID-19INDIANAPOLIS, Feb. 9, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for investigational bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together, Eli Lilly and Company (NYSE: LLY) announced today. This therapy is authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab 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.
In addition, the FDA has authorized infusion times for bamlanivimab alone and bamlanivimab and etesevimab together to be as short as 16 or 21 minutes, respectively – a significant reduction from the previously authorized time of 60 minutes. This decision has been made in response to feedback received from front-line nurses and doctors administering these infusions and are aimed at reducing the burden on the healthcare system.
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The EUA is based on Phase 3 data from the BLAZE-1 trial, announced January 26, 2021, which demonstrated bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70 percent. These data replicate earlier results, published in The Journal of the American Medical Association, in a much larger group of patients. ...
The EUA is based on Phase 3 data from the BLAZE-1 trial, announced January 26, 2021, which demonstrated bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70 percent. These data replicate earlier results, published in The Journal of the American Medical Association, in a much larger group of patients. ...[/quote]
Bamlanivimab was developed by the Canadian company AbCellera under an existing DARPA program. Etesevimab was developed by the Chinese company Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science.
As the article mentions, bamlanivimab has EUA for use by itself. The word I've heard is that basically bamlanivimab works best if used early with people whose symptoms are still moderate. The same seems to be the case with this combination. Since the antibodies attack the virus, it makes sense that use earlier in the infection process would be most beneficial. OTOH, once the virus gets its pneumonia going, that's where the main fight is (BTDTGTTS).
