Eli Lilly (NYSE:LLY) announces positive preliminary results from an NIAID-sponsored clinical trial, ACTT-2, evaluating the combination of baricitinib and Gilead Sciences’ (NASDAQ:GILD) remdesivir in more than 1,000 hospitalized COVID-19 patients.
The study met the primary endpoint of reducing the time to recovery compared to remdesivir. Specifically, there was about a one-day reduction in median recovery time in the baricitinib + remdesivir arm versus the remdesivir alone arm. The effect was statistically significant.
Recovery was defined as the participant being well enough for hospital discharge, meaning the participant either no longer required supplemental oxygen or ongoing medical care in the hospital, or was no longer hospitalized at Day 29.
A key secondary endpoint, patient clinical status at day 15, was also met, although there were 31 total secondary endpoints.
The company plans to discuss potential emergency use authorization with the FDA. If authorized, the JAK1/JAK2 inhibitor, in-licensed from Incyte (NASDAQ:INCY), will be available through commercial channels.
It also plans to review the data with NIAID to assess any impact on another Phase 3, BARRIER, evaluating baricitinib versus background therapy in hospitalized adult COVID-19 patients in the U.S., Europe, Asia and Latin America.
The FDA approved baricitinib, branded as Olumiant, in June 2018 for rheumatoid arthritis.
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