EUA for Lilly, AbCellera COVID mAb despite Phase II miss for authorized dose

FDA’s first emergency use authorization for a SARS-CoV-2-targeting mAb covers the lowest dose of Lilly and AbCellera’s candidate to treat COVID-19 outpatients, a dose that was not effective in the Phase II BLAZE-1 trial in the indication.

The agency said the EUA was based on interim data from the BLAZE-1 trial in which the middle, 2,800 mg, dose of bamlanivimab — but not the authorized dose of 700 mg or the high dose of 7,000 mg — met the primary endpoint of lowering baseline viral loads at day 11 vs. placebo. ...