2022-05-11 06:48:56 LLY Eli Lilly
Incyte
05/11/22 05/1106:48 05/11/2206:48 | FDA approves Lilly, Incyte's OLUMIANT for the treatment of COVID-19Eli Lilly and Company (LLY) and Incyte (INCY) announced the U.S. Food and Drug Administration has approved OLUMIANT for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation 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, 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 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, please see the FDA Letter of Authorization, 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 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 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. Please see additional Important Safety Information below. OLUMIANT is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly. To learn more about OLUMIANT, please visit www.OLUMIANT.com. OLUMIANT is available in the U.S. as 1-mg and 2-mg tablets through Lilly's authorized specialty distributors. Eli Lilly
Incyte
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