By Chris Wack
Eli Lilly & Co. and Incyte Corp. said the U.S. Food and Drug Administration has broadened the emergency use authorization for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir.
The authorization now provides for the use of baricitinib for treatment of Covid-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation.
The companies said the FDA based its decision on data from a Phase 3 study, a randomized, placebo-controlled study of hospitalized patients comparing baricitinib 4 mg once daily plus standard of care versus placebo plus standard of care.
While the composite primary endpoint of the study, which was defined as a difference in the estimated proportion of participants progressing to non-invasive ventilation including high flow oxygen or invasive mechanical ventilation or death by day 28, didn't meet statistical significance, baricitinib-treated patients were less likely than those receiving standard of care to progress to ventilation or death.
A pre-specified key secondary endpoint showed baricitinib, in addition to standard of care, meaningfully reduced the risk of death by 39% by day 28. No new safety signals potentially related to the use of baricitinib were identified.
Under the emergency use authorization, inpatient pharmacies in the U.S. may order 1-mg and 2-mg tablets of baricitinib through Lilly's authorized distributors.
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(END) Dow Jones Newswires