FDA approves Olumiant for certain adults hospitalized with COVID-19

The FDA has approved a new indication for Olumiant as a treatment for adults hospitalized with COVID-19 who require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

The Janus kinase inhibitor Olumiant (baricitinib; Eli Lilly & Co.) is the first immunomodulatory treatment to be approved by the FDA for COVID-19, according to the agency.

The FDA previously granted emergency use authorization (EUA) to baricitinib for use in combination with Veklury (remdesivir; Gilead Sciences) as a treatment for adults and pediatric patients hospitalized with COVID-19. The EUA was later updated to authorize baricitinib as a standalone treatment, the FDA said. The drug remains under EUA status for hospitalized patients aged 2 to 17 years who require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

The new indication of baricitinib is supported by findings from two randomized, double-blind, placebo-controlled phase 3 studies, ACTT-2 and COV-BARRIER, which demonstrated mortality benefits with baricitinib in patients hospitalized with COVID-19, according to the manufacturer.

“More than 2 years into the pandemic, COVID-19 is still hospitalizing many people and burdening our health care 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,” Andre Kalil, MD, MPH, a professor of medicine at the University of Nebraska Medical Center and principal investigator of the ACTT-2 trial, said in a press release from Eli Lilly & Co. “While there are therapies currently available, there is still an urgent need for more options to help improve outcomes for patients hospitalized due to COVID-19.”

The FDA-approved labeling for baricitinib includes a boxed warning about an increased risk for serious infections, including tuberculosis, as well as mortality, malignancy, major adverse cardiovascular events and thrombosis, the manufacturer said.

Reference:

Olumiant prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207924s006lbl.pdf?utm_medium=email&utm_source=govdelivery. Accessed May 11, 2022.