U.S. FDA Approves First JAK Inhibitor for COVID-19 Treatment
Indiana-based Eli Lilly and Company and Incyte announced today the U.S. Food and Drug Administration (FDA) had approved OLUMIANT® (baricitinib), a once-daily, oral Janus kinase (JAK) inhibitor for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
The recommended dosage is 4-mg once daily for 14 days or until hospital discharge, whichever comes first.
Baricitinib has been available in the U.S. under Emergency Use Authorization (EUA) since November 2020.
The EUA will remain in place for hospitalized pediatric patients 2 to less than 18 years old who require various degrees of oxygen support.
"Nearly one million people with COVID-19 have been treated with OLUMIANT (baricitinib) in approximately 15 countries worldwide," said Patrik Jonsson, Lilly SVP, president of Lilly Immunology and Lilly USA, and chief customer officer, in a related press release issued on May 11, 2022.
"Today's full approval reflects 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."
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) announced previously.
No new safety signals potentially related to the use of OLUMIANT were identified in the studies.
Additionally, 75 countries deploy Olumiant to treat adults with moderate to severe rheumatoid arthritis.
Note: Lilly's media statement was manually edited for clarity and mobile readers.