US EUA For Lilly’s Bamlanivimab Conditioned On Additional GMP Compliance Requirements
Executive Summary
Letter of authorization for COVID-19 therapeutic made at troubled Lilly plant requires independent third-party oversight.
You may also be interested in...
The Quality Lowdown: The Warning Letter Monsoons That Might Follow The Inspection Drought
Selective whistleblower allegations, investigative reports hint at drug GMP issues awaiting US FDA inspection resumption; GSK sotrovimab EUA gets root cause provision; API GMP compliance work acknowledged; Aziyo recalls bone matrix associated with tuberculosis outbreak, and other matters in this latest update.
US FDA Authorizes Lilly’s COVID-19 mAB Combo For Lower Doses Than Tested In Phase III
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 Panel No-Go For Lilly’s Antibody In COVID-19
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.