FDA接受鲁索替尼治疗白癜风的补充!

蔺晨公子
发表时间: 2021-12-20
Incyte在一份新闻稿中宣布,对鲁索替尼治疗白癜风的补充新药申请的优先审查已被FDA接受。

Incyte在一份新闻稿中宣布,对鲁索替尼治疗白癜风的补充新药申请的优先审查已被FDA接受。


局部JAK抑制剂Opzelura(ruxolitinib乳膏1.5%)目前已被批准用于治疗12岁及以上患者的轻度至中度特应性皮炎。


白癜风治疗的sNDA基于3期TRuE-V临床试验计划的数据,该计划发现,每天两次接受鲁索利替尼乳膏治疗的白癜风患者中,29.9%的面部白癜风区域评分指数至少改善了75%。


"白癜风是一种慢性自身免疫性疾病,可以对人们的生活产生深远的影响,"Incyte炎症和自身免疫集团副总裁Jim Lee博士说。"目前,没有FDA批准的用于白癜风患者再绝育的药物疗法。FDA接受我们的sNDA用于ruxolitinib乳膏,使我们更接近于为白癜风患者提供额外的治疗选择。


FDA已将处方药用户费用法案日期定为2022年4月18日。




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Rebecca L. Forand

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Ruxolitinib cream improves facial vitiligo in phase 3 trials

December 15, 2021

1 min read

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FDA accepts supplemental NDA for ruxolitinib in vitiligo

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Priority review of a supplemental new drug application for ruxolitinib for the treatment of vitiligo has been accepted by the FDA, Incyte announced in a press release.

A topical JAK inhibitor, Opzelura (ruxolitinib cream 1.5%) is currently approved for the treatment of mild to moderate atopic dermatitis in patients 12 years and older.

The sNDA for vitiligo treatment is based on data from the phase 3 TRuE-V clinical trial program, which found 29.9% of patients with vitiligo who were treated with ruxolitinib cream twice daily had an improvement of at least 75% in facial Vitiligo Area Scoring Index.

“Vitiligo is a chronic autoimmune disease that can have a profound impact on people’s lives,” Jim Lee, MD, PhD, group vice president, inflammation and autoimmunity, Incyte, said in the release. “Currently, there are no FDA-approved drug therapies for repigmentation in people with vitiligo. The FDA’s acceptance of our sNDA for ruxolitinib cream brings us one step closer to offering patients with vitiligo an additional treatment option.”

The FDA has set a Prescription Drug User Fee Act date of April 18, 2022.


(来源:Incyte)

来源: Incyte
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FDA接受鲁索替尼治疗白癜风的补充!
Incyte在一份新闻稿中宣布,对鲁索替尼治疗白癜风的补充新药申请的优先审查已被FDA接受。
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