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FDA Approves Lilly’s OLUMIANT to Treat Certain Hospitalized COVID Patients

OLUMIANT is the first JAK inhibitor FDA-approved for the treatment of COVID-19 in certain hospitalized adults requiring various degrees of oxygen support.

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By: Kristin Brooks

Managing Editor, Contract Pharma

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 saf...

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