First JAK-inhibitor to show hair regrowth in Phase III alopecia trial

US pharma major Eli Lilly (NYSE: LLY) and partner Incyte (Nasdaq: INCY) have released top-line results from BRAVE-AA2, a Phase III study evaluating the efficacy and safety of their once-daily JAK-inhibitor baricitinib 2mg and 4mg in adults with severe alopecia areata (AA).

Both doses of baricitinib, sold as Olumiant for arthritis and atopic dermatitis, met the primary efficacy endpoint at Week 36, demonstrating a statistically-significant improvement in scalp hair regrowth compared to 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 US Food and Drug Administration for the treatment of AA.

There are currently no FDA-approved treatments for AA, a disease that affects as many as 147 million people worldwide. The sell-side forecasts Olumiant sales of $1.2 billion in 2026, according to EvaluatePharma consensus, but none of this is expected to come in alopecia.