FDA Approves Olumiant for New COVID-19 Indication

The FDA approved a new indication for Eli Lilly and Incyte’s Olumiant (baricitinib) for COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval, the FDA said in a news release.

The agency first issued an emergency use authorization (EUA) in November 2020 for Olumiant in combination with remdesivir to treat COVID-19 in hospitalized adults and pediatric patients. In July 2021, the FDA revised the EUA to authorize Olumiant as a stand-alone treatment.

Olumiant remains under EUA status for hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

Patrik Jonsson

“Nearly 1 million people with COVID-19 have been treated with Olumiant in about 15 countries worldwide,” Patrik Jonsson, Lilly senior vice president, president of Lilly Immunology and Lilly USA, and chief customer officer, said in a news release. “The full approval reflects both our confidence in Olumiant’s role in treating these hospitalized patients and Lilly’s tireless efforts to support the medical community and patients in the ongoing fight against COVID-19.”

Olumiant carries a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis, Lilly said. Malignancies and thrombosis have occurred in patients treated with Olumiant and higher rates of each have been observed with another JAK inhibitor versus TNF blockers.

“Patients treated with Olumiant are at an increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis. Higher rates of all-cause mortality and MACE have been observed with another JAK inhibitor versus tumor necrosis factor blockers,” according to Lilly.

The FDA’s approval is supported by results from two placebo-controlled phase 3 studies (ACTT-2 and COV-BARRIER, including the COV-BARRIER OS 7 addendum study).

“No new safety signals potentially related to the use of Olumiant were identified in the studies,” Lilly said.