Baricitinib is a Janus kinase inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation.
Baricitinib is FDA-approved (and sold under the brand name Olumiant) to treat moderately to severely active rheumatoid arthritis.
November 19, 2020, the FDA issued an emergency use authorization (EUA) to use baricitinib, in combination with remdesivir (Veklury), for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
However, baricitinib is not authorized or approved as a stand-alone treatment for COVID-19.
Baricitinib is a prescription oral tablet. The recommended dose for this EUA is baricitinib 4-mg once daily for 14 days or until hospital discharge.
April 8, 2021 - Eli Lilly and Company and Incyte announced results of COV-BARRIER, a Phase 3 study evaluating baricitinib 4 mg once daily plus standard of care (SoC) versus placebo plus SoC. The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28. Baricitinib-treated patients were 2.7 percent less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death, a difference that was not statistically significant (odds ratio [OR]: 0.85; 95% CI 0.67, 1.08; p=0.1800).
March 3, 2021 - Eli Lilly and Company and Incyte announced top-line results from BRAVE-AA2, a Phase 3 study evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA). Both doses of baricitinib met the primary efficacy endpoint at Week 36, demonstrating a statistically significant improvement in scalp hair regrowth than those randomized to placebo. AA is an autoimmune disease that causes patchy hair loss on the scalp, face, and sometimes on other areas of the body that can progress. Baricitinib has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of AA. This classification aims to expedite the development and review of drugs intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over already available therapies on a clinically significant endpoint(s). There are currently no FDA-approved treatments for AA.
November 19, 2020 - Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19.
Baricitinib Clinical Trials
Clinical Trial NCT04401579: Adaptive COVID-19 Treatment Trial 2 (ACTT-2) Study Completion date: July 31, 2020.