It will be interesting to see if Sotrvimab is the first monoclonal antibody approved for mild to moderate Covid19. Most of the other monoclonals are now seeking approval for prophylaxisis in high risk patients since they were unable to show efficacy in the mild,moderate or severely ill Covid 19 patients.
Sotrovimab had some very positive attributes. It was effective at a low dose,it appears to be reasonably safe with good pharmocokinetics.
You can look at statistics in different ways. The authors summary showed statistical validity:
... interim study results demonstrated an 85% (p=0.002) reduction in hospitalization for more than 24 hours or death in those receiving sotrovimab compared to placebo.
Another way to look at the results was they treated 583 high risk patients to prevent 1 death and 18 hospitalizations {21-3}.
While that would probably warrant approval in the US, Japan or EU. I am not sure that other countries would find that calculation enough of a value to extend treatment to the high risk individuals.
The other monoclonal antiboies for Covid failed to show good results when large numbers of patients were treated.
We will have to wait until Sotrovimab completes its studies.
GLTA Farrell
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