Olumiant, Remdesivir Combo Shows Promise as COVID-19 Treatment

A late-stage trial of Eli Lilly’s rheumatoid arthritis (RA) treatment Olumiant (baricitinib) and Gilead Sciences’ remdesivir found that the combination reduced recovery time in hospitalized COVID-19 patients compared to remdesivir alone.

The Adaptive COVID-19 Treatment Trial 2 (ACTT-2), a global trial at approximately 100 sites that is led by the National Institutes of Health (NIH), is evaluating the combination of baricitinib and remdesivir compared to remdesivir alone. The NIH phase 3 trial of 1,000 patients found that adding Olumiant reduced recovery time by about one day in patients given the combination compared with those treated only with remdesivir.

Baricitinib is a JAK1/JAK2 inhibitor licensed to Eli Lilly from Incyte, and it appears to be  useful in warding off the cytokine storm from the immune system often seen in very ill COVID-19 patients. The combination treatment met the primary endpoint of reducing the time to recovery, defined as the participant being well enough for hospital discharge, no longer requiring supplemental oxygen or ongoing medical care in the hospital, or no longer being hospitalized at Day 29.

Based on the ACTT-2 data, Lilly plans to discuss the potential for an Emergency Use Authorization (EUA) with the FDA and similar measures with other regulatory agencies.

In the U.S., baricitinib is approved for RA patients at a 2-mg daily dose; an EUA would potentially authorize a 4-mg dose for COVID-19 patients. If authorized for use, Lilly will propose that baricitinib be made available through normal sales and distribution channels, rather than be distributed from a government stockpile, and said it will work with hospitals and governments to ensure patient access. — Suz Redfearn