Lilly’s EUA Timeline For COVID-19 Combo Antibody Depends On Safety Data, Manufacturing
Single neutralizing antibody moves to US FDA with data showing reduced hospitalization, while Lilly’s EUA filing for two-antibody combo awaits safety data and more certainty about production capabilities.
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Among hundreds of trials underway on potential therapeutics, only about 6% of study arms are expected to yield actionable data because most are nonrandomized, underpowered or underenrolled, Operation Warp Speed’s Janet Woodcock says, renewing her pitch for adoption of master protocols and other approaches to streamline studies and improve efficiency.
Trump receives Regeneron’s experimental antibody under FDA’s expanded access program, Gilead’s remdesivir and dexamethasone. The president’s treatment choices could influence clinical trials of all COVID-19 medicines and even trial recruitment for other diseases, experts said.