US EUA For Lilly’s Bamlanivimab Conditioned On Additional GMP Compliance Requirements
Letter of authorization for COVID-19 therapeutic made at troubled Lilly plant requires independent third-party oversight.
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The doses of bamlanivimab and etesevimab authorized for use in combination are a fraction of those shown to be effective in the Phase III BLAZE-1 trial; however, Phase II data, PK/PD modeling and in vitro data suggest the lower doses will have the same clinical impact as the higher-dose regimen, the FDA said.
India expert panel decides not to back Lilly’s bamlanivimab as a COVID-19 therapy, at least for now, under the accelerated approval route and without local trials, but the US firm is still pursuing an authorization request. Physicians underscore the need for more data on important patient outcomes for the antibody product.
Under pressure to authorize use of Lilly’s bamlanivimab, the FDA must first weigh efficacy signals and GMP plant remediation progress.