礼来的JAK抑制剂Baricitinib治疗斑秃,获得FDA授予突破性疗法称号

2020-03-19 MedSci原创 MedSci原创

Baricitinib治疗斑秃已获得FDA的突破性疗法称号,斑秃是一种自身免疫性疾病,没有FDA批准的疗法。

礼来公司的口服JAK抑制剂Olumiant(baricitinib)片剂治疗斑秃,获得美国食品药品监督管理局(FDA)授予突破性疗法称号。斑秃是一种自身免疫性疾病,目前没有FDA批准的治疗药物。

该称号授予是基于自II/III期临床研究BRAVE-AA1中II期研究的结果,该研究评估了成年斑秃患者中Baricitinib与安慰剂相比的疗效和安全性。在II期研究中,没有不良反应的报道,最常见的副作用是上呼吸道感染、鼻咽炎和痤疮。

礼来公司免疫学发展副总裁Lotus Mallbris博士说:"患有斑秃的患者目前没有任何FDA批准的治疗药物。斑秃不仅会导致脱发,还会对患有这种疾病的人造成心理负担。在礼来公司,我们渴望创造可以给患者带来希望的新药。我们期待与FDA合作,进一步探索baricitinib成为首个获批治疗斑秃的潜力。"

Baricitinib 2mg剂量目前已批准用于治疗中度至重度活动性类风湿关节炎(RA)成人患者。

原始出处:

https://www.europeanpharmaceuticalreview.com/news/115299/olumiant-baricitinib-granted-breakthrough-therapy-designation-by-fda/

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    2020-07-19 jklm09
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