FDA Expands Approval of Olumiant to Include Hospitalized Adult COVID-19 Patients

The FDA approved Eli Lilly and Incyte’s blockbuster Janus kinase inhibitor Olumiant (baricitinib) for treatment of adult COVID-19 patients who are hospitalized and need oxygen or a ventilator.

An Emergency Use Authorization (EUA) remains in place for hospitalized pediatric COVID-19 patients age two years and older who need oxygen or a ventilator.

Olumiant, which was first approved in 2018 for the treatment of patients with moderate-to-severe rheumatoid arthritis, received an EUA on Nov. 19, 2020, for use in combination with Gilead Sciences’ Veklury (remdesivir) for the treatment of hospitalized adult and pediatric COVID-19 patients.

In July 2021, the EUA was revised to allow Olumiant’s use as a monotherapy in COVID-19 patients.

Olumiant earned more than $1.1 billion in sales last year.