Eli Lilly and Co. (LLY) and Incyte (INCY) announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The recommended dosage is 4-mg once daily for 14 days or until hospital discharge, whichever comes first.
OLUMIANT is the first and only JAK inhibitor FDA-approved for the treatment of COVID-19 in certain hospitalized adults requiring various degrees of oxygen support.
The FDA's approval is supported by results from two randomized, double-blind, placebo-controlled Phase 3 studies (ACTT-2 and COV-BARRIER, including the COV-BARRIER OS 7 addendum study), announced previously. No new safety signals potentially related to the use of OLUMIANT were identified in the studies.
Baricitinib has been available in the U.S. under Emergency Use Authorization (EUA) since November 2020.
Lilly has submitted applications for regulatory approval or authorization to multiple regulatory agencies around the world and anticipates further regulatory decisions to follow.
OLUMIANT is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is available in the U.S. as 1-mg and 2-mg tablets through Lilly's authorized specialty distributors.
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