Questions Remain On Gilead’s Remdesivir
Remdesivir shows ability to yield clinical improvement in moderately ill COVID-19 patients, but data are called ‘modest’ and shorter therapy duration showed better results than longer.
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The FDA emphasized the rigor of its review of the first COVID-19 therapy, which used few expedited pathways on its way to approval after a two-and-a-half-month review. Post-marketing studies will address remaining concerns about dosing and special populations.
Gilead says remdesivir improved mortality and clinical recovery in COVID-19 patients, but the findings come from a retrospective analysis, not a traditional clinical trial.
Gilead will study inhalable remdesivir in volunteers, then hopefully in August as an earlier COVID-19 treatment. Analyst says production of 2m-plus I.V. doses by year-end could mean blockbuster revenues.