Press release
OLUMIANT® Significantly Improved Hair Regrowth to At Least 80% Scalp Coverage as Early as 24 Weeks Across First Completed Phase 3 Studies for Alopecia Areata
- Potential first-in-disease treatment for millions of adults worldwide living with alopecia areata (AA) - - Safety data in AA showed no new safety signals
About this update from Incyte Corporation
[{"type":"text","content":"- Potential first-in-disease treatment for millions of adults worldwide living with alopecia areata (AA) -\n - Safety data in AA showed no new safety signals for OLUMIANT up to 36 weeks of treatment in the longest Phase 3, placebo-controlled period for the JAK inhibitor class to date -\n - Tolerability of OLUMIANT was further demonstrated for acne, headache, and GI events in pooled analysis across eight studies of 2,500 patients with atopic dermatitis -\n\n\nINDIANAPOLIS, Sept. 30, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today detailed results from two pivotal Phase 3 trials (BRAVE-AA1 and BRAVE-AA2), which found once-daily OLUMIANT® (baricitinib) 4-mg was superior to placebo in achieving significant scalp hair regrowth as early as 24 weeks in adults with severe alopecia areata (AA) as defined by ≥50% scalp hair loss at baseline. \nSignificant improvements in scalp hair regrowth compared to placebo were achieved at 36 weeks for patients taking OLUMIANT 2-mg and 4-mg oral doses, as previously disclosed in topline findings from BRAVE-AA1 and BRAVE-AA2 earlier this year. In both studies, a greater proportion of patients taking OLUMIANT 4-mg compared to placebo also achieved full regrowth or regrowth with minimal gaps in coverage of eyebrow and eyelash hair at 36 weeks, which were key secondary endpoints of the studies.\nThese results, along with safety data in adult patients with moderate to severe atopic dermatitis (AD), are being presented virtually at the 30th European Academy of Dermatology and Venerology (EADV) Congress, taking place from Sept. 29-Oct. 2, 2021. \nAlopecia areata is a widely misunderstood, autoimmune disease that can cause extreme and patchy hair loss on the scalp, face and other areas of the body, along with emotional distress and psychosocial effects. OLUMIANT has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of AA. Lilly plans to submit a supplemental New Drug Application (sNDA) to the FDA for OLUMIANT in AA in the second half of 2021.\nOLUMIANT Demonstrated Improvement in Scalp, Eyelash and Eyebrow Hair Regrowth in Patients with AA in Two Phase 3 Trials\nIn BRAVE-AA1 and BRAVE-AA2, the first completed, randomized, double-blind, placebo-controlled Phase 3 trials for AA, 598 and 490 patients, resp...