FDA approves Olumiant for COVID-19.
Eli Lilly announced that the 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 III 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.
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