Covid-19 roundup: Eli Lilly's RA drug gets solo OK from FDA; Emergent gets greenlight to resume manufacturing at Bayview site
The FDA late Wednesday extended the EUA for Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) to be used as a solo treatment for Covid-19 in hospitalized adults and pediatric patients who need supplemental oxygen.
The oral drug was previously cleared in conjunction with Gilead’s remdesivir to treat those hospitalized with Covid-19.
In a Phase III study reported in April, Olumiant did not meet its primary endpoint. The drug failed to reach statistical significance for the difference in rate of patients needing non-invasive or invasive ventilation for the first time, or those who died after 4 weeks. But FDA said that the revised EUA for baricitinib was supported by data from that study, which showed a reduction in the proportion of patients who died after 4 weeks of follow-up compared to patients treated with the standard of care alone.
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