Eli Lilly and Co. and Incyte announced positive 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.
baricitinib is the first JAK-Inhibitor to demonstrate hair regrowth in phase 3 alopecia areata trial, the companies said in a statement.
According to the companies, both doses of baricitinib met the primary efficacy endpoint at Week 36, demonstrating a statistically significant improvement in scalp hair regrowth compared to those randomized to placebo.
Data from an additional Phase 3 study of baricitinib in AA will be available in the first half of this year.
alopecia areata 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 for the treatment of alopecia areata.
Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is approved and commercially available as OLUMIANT in the U.S. and more than 70 countries as a treatment for adults with moderate to severe active RA and in the European Union and Japan for the treatment of adult patients with moderate to severe AD who are candidates for systemic therapy.
Baricitinib is also being investigated in systematic lupus erythematosus, juvenile idiopathic arthritis and COVID-19.
OLUMIANT or baricitinib 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.
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