SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19

In interim analysis of phase 2 trial (n=452), 1 of 3 doses (2800mg) of this neutralising antibody (bamlanivimab) appeared to accelerate natural decline in viral load over time (difference from placebo in decrease from baseline −0.53; p=0.02), whereas other doses had not by day 11

SPS commentary:

These data were submitted as part of Lilly's request for an Emergency Use Authorization (EUA) from the FDA for bamlanivimab in higher-risk patients who have been recently diagnosed with mild to moderate COVID-19.

The company have announced an initial agreement with the U.S. government to supply 300,000 vials of bamlanivimab 700mg for $375 million. The U.S. government will accept the vials if EUA is granted

Lilly has also announced that based on an updated dataset from NIH’s ACTIV-3 Clinical Trial reviewed on October 26, no additional COVID-19 patients in this hospitalized setting will receive bamlanivimab as the data suggest that it is unlikely to help hospitalized COVID-19 patients recover from this advanced stage of their disease.

Source:

New England Journal of Medicine

Resource links:

Lilly Statement- NIH’s ACTIV-3 Clinical Trial

Press release - supply to US