Baricitinib Now Fully Approved for COVID-19 Treatment in Hospitalized Adults

The FDA has fully approved the use of baricitinib (Olumiant) in combination with remdesivir (Veklury) for the treatment of suspected or laboratory-confirmed COVID-19 in certain hospitalized patients requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. Prior to the full approval, baricitinib was originally authorized in November 2020 under an Emergency Use Authorization.

FDA’s full approval was based on data from two phase 3 trials and an addendum study that evaluated the efficacy and safety of baricitinib 4 mg in hospitalized adults with COVID-19. No new safety signals potentially related to the use of baricitinib were identified in the studies. Nearly one million people with COVID-19 have been treated with baricitinib in 15 countries worldwide.

Baricitinib’s prescribing information carries a Boxed Warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. Consult product labeling for full prescribing information and precautions. Barricitinib is a product of Lilly.