Eli Lilly and Company and Incyte received approval from the U.S. FDA for 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) with a recommended dose of 4-mg once daily for 14 days or until hospital discharge, whichever comes first.
 
The approval is based on results from two randomized, double-blind, placebo-controlled Phase 3 studies. 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 since November 2020. An EUA will remain in place for hospitalized pediatric patients 2 to less than 18 years old who require various degrees of oxygen support. 
 
Lilly has submitted applications for regulatory approval or authorization to multiple regulatory agencies around the world and anticipates further regulatory decisions to follow.
 
The U.S. FDA-approved labeling for OLUMIANT carries a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis. Patients treated with OLUMIANT are at an increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis. Higher rates of all-cause mortality and MACE have been observed with another JAK inhibitor versus tumor necrosis factor (TNF) blockers. Malignancies and thrombosis have occurred in patients treated with OLUMIANT and higher rates of each have been observed with another JAK inhibitor versus TNF blockers.