Eli Lilly and Company and Incyte announced 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) with a recommended dose of 4-mg once daily for 14 days or until hospital discharge, whichever comes first. 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. An EUA will remain in place for hospitalized pediatric patients 2 to less than 18 years old who require various degrees of oxygen support. The emergency authorization is not an approval and is temporary for the duration where circumstances justify the authorization.

For additional information about the authorized use, Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers. 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.

Consider the risks and benefits of treatment prior to initiating or continuing therapy with OLUMIANT. OLUMIANT is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly. OLUMIANT is available in the U.S. as 1-mg and 2-mg tablets through Lilly's authorized specialty distributors.

About ACTT-2 (COVID I) Study:- ACTT-2 was a randomized, double-blind, placebo-controlled clinical trial of certain hospitalized adults with confirmed SARS-CoV-2 infection that compared treatment with OLUMIANT and remdesivir (combination group; n=515) to treatment with placebo and remdesivir (placebo group; n=518). Patients treated with the combination received OLUMIANT 4-mg once daily (orally) for 14 days or until hospital discharge, whichever was first, and remdesivir 200-mg on Day 1 and 100-mg once-daily (via intravenous infusion) on subsequent days for a total treatment duration of 10 days or until hospital discharge, whichever was first. The primary endpoint, for the intent to treat population, was time to recovery within 29 days after randomization.

Recovery was defined as being discharged from the hospital without limitations on activities, being discharged from the hospital with limitations on activities and/or requiring home oxygen, or hospitalized but not requiring supplemental oxygen and no longer requiring medical care. The key secondary endpoint was clinical status on Day 15, as assessed on an 8-point ordinal scale.