The long list of therapeutic uses for Sanofi and Regeneron's Dupixent has been lengthened, after the drug became the first FDA-approved therapy for rare and debilitating skin disease bullous pemphigoid (BP).

赛诺菲和再生元公司的Dupixent的长串治疗用途又增加了，该药成为首个获FDA批准的罕见且使人衰弱的皮肤疾病——大疱性类天疱疮（BP）的疗法。

BP

BP

primarily affects elderly patients and causes reddening of the skin and the formation of painful and intensely itchy chronic lesions and blisters, in some cases spreading across a majority of the body. It is estimated to affect around 27,000 people in the US, mainly aged 60 to 80, who can have their daily activities drastically compromised and become prone to infections..

主要影响老年患者，导致皮肤发红，并形成疼痛和剧烈瘙痒的慢性病灶和水疱，有时会蔓延至身体大部分区域。据估计，美国约有27,000人受此影响，主要是60至80岁的老年人，他们的日常活动可能受到严重影响，并容易感染。

IL-4 and IL-13 inhibitor Dupixent (dupilumab) is the first biologic drug to show an improvement in remission and symptoms in BP, and the first to allow patients to reduce the use of steroids, which are the standard therapy for the disorder but can have serious long-term side effects.

IL-4和IL-13抑制剂Dupixent（dupilumab）是首个在BP中显示出缓解和症状改善的生物药物，也是首个让患者减少使用标准治疗类固醇的药物，而类固醇虽然作为该疾病的常规疗法，但可能带来严重的长期副作用。

The FDA approval is based mainly on the

FDA 的批准主要基于

ADEPT

熟练的

study reported last year, which showed that the drug achieved a five-fold greater sustained remission rate at 36 weeks – 20% versus 4% – compared to placebo, without the need for steroid rescue therapy.

去年报道的一项研究显示，与安慰剂相比，该药物在 36 周时实现了高出五倍的持续缓解率（20% 对比 4%），且无需类固醇抢救疗法。

In addition, 41% of Dupixent-treated patients achieved a 90% or greater reduction in disease severity, compared to 10% of the control group, while 'clinically meaningful' itch reduction was recorded in 40% and 11%, respectively. Itch is often reported to be one of the most damaging symptoms to BP patients' quality of life..

此外，41%的接受Dupixent治疗的患者疾病严重程度降低了90%或更多，而对照组中这一比例为10%，同时分别有40%和11%的患者报告了“具有临床意义”的瘙痒减轻。瘙痒常被认为是BP患者生活质量中最具有破坏性的症状之一。

The approval has been hailed by the International Pemphigus and Pemphigoid Foundation (IPPF), whose executive director – Patrick Dunn – said: 'Dupixent is the first targeted medicine to allow patients the potential to achieve sustained remission and reduce itch.'

国际天疱疮和类天疱疮基金会 (IPPF) 对此批准表示欢迎，其执行董事帕特里克·邓恩表示：“Dupixent 是首个能让患者有望实现持续缓解并减轻瘙痒的靶向药物。”

He added: 'This approval in the US is important for the thousands of patients living with bullous pemphigoid, and we look forward to working with regulators around the world to bring this innovative medicine to more patients in need.'

他补充说：「这种药物在美国获得批准对数千名患有大疱性类天疱疮的患者而言意义重大，我们期待与全球监管机构合作，将这种创新药物带给更多有需要的患者。」

Additional applications for Dupixent as a treatment for BP are also under review around the world, including in the EU, Japan, and China, said Sanofi and Regeneron, which also have trials of the drug on the go in additional indications, including chronic pruritus of unknown origin and lichen simplex chronicus..

赛诺菲和再生元表示，Dupixent作为BP治疗方案的其他应用也在全球范围内接受审查，包括欧盟、日本和中国。这两家公司还在进行该药物在其他适应症方面的试验，包括不明原因的慢性瘙痒和慢性单纯性苔藓。

Dupixent is now approved to treat eight diseases characterised by type 2 inflammation in the US, including atopic dermatitis and asthma, and has grown into a huge product with sales topping $14 billion last year. Recent approvals in chronic obstructive pulmonary disease (COPD) and now BP suggest there is still plenty of growth left in the tank for the product..

Dupixent目前已在美国获批用于治疗八种以2型炎症为特征的疾病，包括特应性皮炎和哮喘，并已发展成为一款销售额去年超过140亿美元的重磅产品。近期在慢性阻塞性肺病（COPD）和如今嗜酸性食管炎（BP）方面的获批表明，该产品仍有巨大的增长空间。