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.
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Former US FDA commissioners say that data for Lilly and Regeneron’s authorized mABs suggesting that reduced viral load correlates with clinical benefit potentially paves the way for emergency authorization or accelerated approval of mABs specifically designed to target emerging variants of the SARS-CoV-2 virus.
Acting CDER Director Cavazzoni says it is ‘a very active time’ as many clinical trials for COVID-19-related products are expected to read out soon.
US FDA's EUA allows lower doses of the two antibodies than were tested in BLAZE-1, which should extend current supply. With Amgen, Lilly hopes to manufacture 1 million doses by mid-year.