Novartis is on course to expand the label for its recently approved oral BTK inhibitor Rhapsido, after chalking up a win in chronic skin disorder chronic inducible urticaria (CINDU).

诺华公司最近批准的口服BTK抑制剂Rhapsido在慢性皮肤疾病慢性诱导性荨麻疹（CINDU）中取得了成功，有望扩大该药物的适应症。

According to the Swiss pharma group,

根据瑞士制药集团，

Rhapsido

狂想曲

(remibrutinib) achieves significantly higher complete response rates in the three most common forms of CINDU - symptomatic dermographism, cold urticaria, and cholinergic urticaria – compared to placebo in the phase 3

（雷米鲁替尼）在三种最常见的CINDU形式——症状性皮肤划痕症、寒冷性荨麻疹和胆碱能性荨麻疹中，与安慰剂相比，在第三阶段实现了显著更高的完全缓解率。

RemIND

提醒

trial.

试验。

CINDU is a group of conditions, affecting around 0.5% of the global population with 29 million cases worldwide, that is characterised by hives or swelling in response to physical stimuli.

CINDU是一组影响全球约0.5%人口的疾病，全球共有2900万病例，其特征是因物理刺激而出现荨麻疹或肿胀。

In the case of dermographism, that can be friction or light scratching of the skin, while low temperatures – particularly cold water or wind – are the trigger in cold urticaria. Cholinergic urticaria, meanwhile, can result from exercise, strong emotions, or bathing in hot water.

对于皮肤划痕症，可能是摩擦或轻微抓挠皮肤引起的，而低温——尤其是冷水或寒风——是寒冷性荨麻疹的诱因。与此同时，胆碱能性荨麻疹可能由运动、强烈情绪或洗热水澡引发。

Rhapsido is already cleared to treat chronic spontaneous urticaria (CSU), in which patients suffer hives and swelling with no known cause and is roughly twice as common as CINDU, with an incidence of around 1% of the global population, according to Novartis.

根据诺华公司的说法，Rhapsido 已被批准用于治疗慢性自发性荨麻疹（CSU），在这种疾病中，患者会出现原因不明的荨麻疹和肿胀，其发病率约为 CINDU 的两倍，全球约有 1% 的人口受到影响。

The company added that it has already filed for approval of the drug for symptomatic dermographism, which is the most common form of CINDU, and will follow up with additional filings around the world – for all three forms – in the coming months.

该公司补充说，它已经为这种最常见形式的CINDU（症状性皮肤划痕症）申请了药物批准，并将在未来几个月内在全球范围内跟进提交其他三种形式的药物批准申请。

If approved, Rhapsido could become the first targeted therapy approved for CINDU, which is typically managed by avoiding triggers and the use of second-generation antihistamines, as well as off-label treatment with other drugs, including Roche's anti-IgE antibody Xolair (omalizumab). RemIND enrolled 364 patients whose CINDU symptoms were not controlled using antihistamines..

如果获得批准，Rhapsido可能成为首个获准用于治疗CINDU的靶向疗法，该疾病通常通过避免诱因、使用第二代抗组胺药以及包括罗氏的抗IgE抗体Xolair（奥马珠单抗）在内的其他药物的超适应症治疗来管理。RemIND研究招募了364名使用抗组胺药无法控制CINDU症状的患者。

'Today's findings reinforce that remibrutinib could be the first targeted therapy to improve spontaneous and inducible forms of chronic urticaria, helping address a major gap in care for people living with these conditions,' commented Angelika Jahreis, Novartis' head of immunology development.

“今天的发现进一步证实了remibrutinib可能成为首个改善自发性和诱发性慢性荨麻疹的靶向疗法，有助于弥补这些患者护理中的重大空白，”诺华免疫学开发主管Angelika Jahreis评论道。

The new indication could also give Novartis a niche indication where it will not have to compete with Sanofi and Regeneron's huge-selling anti-IL-4 and IL-13 antibody Dupixent (dupilumab), which was

新的适应症也可能为诺华提供一个利基市场，在这个市场中，它将不必与赛诺菲和再生元的畅销抗IL-4和IL-13抗体Dupixent（dupilumab）竞争，该药物是

cleared

已清除

for CSU last year, adding to a long list of approved indications.

去年，CSU 再次获得批准，增加了许多已批准的适应症。

Dupixent has also been tested in previous clinical trials for CINDU, with initial results reported in cold urticaria. However, Sanofi's latest pipeline listing suggests it is now focusing on another candidate, KIT inhibitor SAR449028, which is in phase 2 testing. It also has an oral BTK drug (rilzabrutinib) in mid-stage testing for CSU..

Dupixent 也在之前针对 CINDU 的临床试验中进行了测试，并在寒冷性荨麻疹中报告了初步结果。然而，赛诺菲最新的研发管线列表显示，目前其重点已转向另一种候选药物——KIT 抑制剂 SAR449028，该药物正在进行二期试验。此外，它还有一种口服 BTK 药物（rilzabrutinib）正在中期测试中用于治疗 CSU。

Rhapsido was approved in the US last September and started rolling out onto the market towards the end of the year. So far, the company hasn't reported any sales figures but Novartis CEO Vas Narasimhan pointed to 'encouraging' take-up in CSU patients refractory to antihistamines as well as after the failure of biologics, in the company's fourth-quarter 2025 results update..

Rhapsido 于去年九月在美国获批，并在年底开始逐步进入市场。迄今为止，该公司尚未报告任何销售数据，但在公司2025年第四季度的业绩更新中，诺华首席执行官瓦斯·纳拉希曼指出，在对传统抗组胺药无效的CSU患者以及生物制剂失败后的患者中，该药物的使用情况“令人鼓舞”。

'Rhapsido is one of these brands that we hope over time could become one of the largest…in Novartis' history,' he continued, saying the early take-up is 'right in line with some of the most successful dermatology launches.'

“Rhapsido是我们希望随着时间的推移能够成为诺华历史上最大品牌之一的品牌，”他继续说道，早期的接受度“与一些最成功的皮肤病学产品发布完全一致”。