Lilly : Phase 3 Study On Baricitinib Meets Primary Endpoint Of Hair Regrowth


2021-03-12 07:00:19 RTTNews


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. For comments and feedback contact:
Eli Lilly公司和Incyte公司公布了BRAVE-AA2的阳性结果,这是一项3期研究,评估了每日一次的巴利替尼2-mg和4-mg治疗严重斑秃的成人的有效性和安全性。 巴利替尼是第一个在3期斑秃试验中证明头发再生的JAK抑制剂,该公司在一份声明中说。 根据这两家公司的说法,两种剂量的巴里替尼在第36周达到了主要疗效终点,与安慰剂组相比,头皮毛发再生有统计学意义上的改善。 今年上半年将会有额外的巴利替尼第三阶段研究的数据。 斑秃是一种自身免疫性疾病,会导致头皮、面部、有时身体其他部位的斑块状脱发。巴利替尼已获得美国食品和药物管理局的突破性疗法指定,用于治疗斑秃。 Baricitinib是Incyte发现的一种口服JAK抑制剂,并被Lilly授权使用。OLUMIANT在美国和70多个国家被批准用于治疗中度到重度活动性RA的成人,在欧盟和日本用于治疗中度到重度AD的成人患者,这些患者是系统治疗的候选者。 巴利替尼也在系统性红斑狼疮、幼年特发性关节炎和新冠肺炎中被调查。 OLUMIANT或baricitinib 2-mg用于治疗对一种或多种肿瘤坏死因子拮抗剂治疗反应不足的中度至重度活动性类风湿性关节炎成人患者。 如需评论和反馈,请联系