FDA Approves Lilly and Incyte's OLUMIANT (baricitinib) for Hospitalized Patients with COVID-19

The U.S. Food and Drug Administration (FDA) has approved OLUMIANT^® (baricitinib) for the treatment of COVID-19 in hospitalized patients. OLUMIANT is a once-daily, oral JAK inhibitor developed by Incyte INCY and licensed to Eli Lilly and Company LLY. 

The regulatory approval is supported by results from Phase 3 studies of ACTT@ and COV-BARRIER. No new safety signals potentially related to the use of OLUMIANT were identified in the studies.

FDA granted Emergency Use Authorization (EUA) for Baricitinib in November 2020, and will remain in place for hospitalized pediatric patients 2 to less than 18 years old.

Andre Kalil, Professor of Medicine at the University of Nebraska Medical Center, said, "More than two years into the pandemic, COVID-19 is still hospitalizing many people and burdening our healthcare system. I'm grateful to have OLUMIANT as a treatment option for those who require various degrees of respiratory support, from supplemental oxygen to mechanical ventilation or ECMO”.

Eli Lilly has submitted applications to multiple regulatory agencies, and anticipates further regulatory decisions from around the world.

Shares of Incyte is trading up 4 percent at $76.14, while Eli Lilly is trading up 2 percent at $290.55 in the pre-market session.