The FDA has approved Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO), according to Eli Lilly and Company, and Incyte.
The drug is a once-daily, oral JAK inhibitor and the first immunomodulatory treatment for COVID-19 to receive FDA approval. The recommended dose of Olumiant is 4-mg once daily for 14 days or until hospital discharge, whichever comes first, the companies noted.
The FDA first issued an emergency use authorization (EUA) for Olumiant in combination with remdesivir to treat COVID-19 in hospitalized adults and pediatric patients on November 19, 2020. On July 28, 2021, the FDA revised the EUA to authorize Olumiant as a standalone treatment. Olumiant remains under EUA status for hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or ECMO.
The FDA’s approval is supported by results from two randomized, double-blind, placebo-controlled Phase 3 studies (ACTT-2 and COV-BARRIER, including the COV-BARRIER OS 7 addendum study).
The US FDA-approved labeling for Olumiant carries a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis, the companies noted. Full safety information is available at the FDA website.
“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,” said Andre Kalil, MD, MPH, Professor of Medicine at the University of Nebraska Medical Center and principal investigator of the Adaptive COVID-19 Treatment Trial 2 (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). “I’m encouraged by the FDA’s full approval of Olumiant for the treatment of these patients based on results from the rigorous, placebo-controlled, double-blind, randomized trials. 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 has revised the Letter of Authorization and associated fact sheets to remove the population covered under the approved indication. Common side effects of Olumiant and the recommended dosage for the approved population are included in the prescribing information.
“Nearly one million people with COVID-19 have been treated with Olumiant (baricitinib) in approximately 15 countries worldwide,” said Patrik Jonsson, Lilly senior vice president, president of Lilly Immunology and Lilly USA, and chief customer officer. “Today’s 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.”