Promising data for Lilly’s COVID-19 mAb leave FDA with a tough call

Interim Phase II data for an antiviral mAb from Lilly and AbCellera to treat COVID-19 outpatients appear to meet FDA’s minimum requirements for emergency use authorization, but the agency will have to grapple with several difficult questions before deciding whether it’s appropriate to grant an EUA to the therapy.

Eli Lilly and Co. (NYSE:LLY) said Wednesday that the middle of three doses of LY-CoV555 met the co-primary endpoint of reducing viral loads at day 11 from baseline levels in mild-to-moderate COVID-19 patients. The mAb, which was well tolerated, led to no serious adverse events in the double-blind BLAZE-1 trial...