Health
Lilly's baricitinib delivered near-complete scalp hair regrowth at one year for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS trial
New results from Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) showed once-daily, oral baricitinib 4 mg helped the majority of adolescent patients (ages 12 to <18) with severe alopecia areata (AA) achieve successful hair regrowth on the scalp, eyebrows and eyelashes at one year. These 52-week results from the BRAVE-AA-PEDS trial – the largest Phase 3 study of its kind – will be presented at the 2025 Fall Clinical Dermatology (FCD) Conference, taking place Oct. 23-26 in Las Vegas.1
About this update from Incyte Corporation
[{"type":"text","content":"This trial is the first and largest study specifically designed to evaluate children and adolescents with severe alopecia areata, a population often underrepresented in clinical trials ","length":184,"tagName":"p","attribs":{}},{"type":"text","content":"New data show 71% of adolescents with severe disease treated with baricitinib 4 mg achieved successful scalp hair regrowth at one year, with continuous improvements observed throughout those 52 weeks","length":199,"tagName":"p","attribs":{}},{"type":"text","content":"Lilly intends to submit the BRAVE-AA-PEDS data to global regulators for a potential label update for baricitinib (commercially available as Olumiant)","length":149,"tagName":"p","attribs":{}},{"type":"text","content":"INDIANAPOLIS, Oct. 24, 2025 /PRNewswire/ -- New results from Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) showed once-daily, oral baricitinib 4 mg helped the majority of adolescent patients (ages 12 to <18) with severe alopecia areata (AA) achieve successful hair regrowth on the scalp, eyebrows and eyelashes at one year. These 52-week results from the BRAVE-AA-PEDS trial – the largest Phase 3 study of its kind – will be presented at the 2025 Fall Clinical Dermatology (FCD) Conference, taking place Oct. 23-26 in Las Vegas.1","length":546,"tagName":"p"},{"type":"text","content":"These data build on 36-week results from the BRAVE-AA-PEDS trial previously presented at the 2025 American Academy of Dermatology (AAD) annual meeting in March.","length":160,"tagName":"p"},{"type":"text","content":""For nearly half of the people with severe alopecia areata, the disease starts before adulthood and can progress quickly, significantly impacting patients' lives," said Nicole Friedland, President and CEO, National Alopecia Areata Foundation (NAAF). "Given the profound burden of this disease, new treatment options are needed for children and adolescents, populations that have been underrepresented for far too long."","length":443,"tagName":"p"},{"type":"text","content":"At the start of the study, patients had an average of 89% scalp hair loss, with 63.8% of them having very severe AA at baseline (Severity of Alopecia Tool [SALT] score 95-100).1 In addition, 65% had minimal or no eyebrow hair (clinician-reported outcome [ClinRO] score of 2 or 3) and 57% had minimal or no ey...