FDA批准Rhapsido新适应症：成为首个治疗症状性皮肤划痕症的药物
诺华公司10月7日在新泽西州东汉诺威宣布，美国食品药品监督管理局（FDA）已批准Rhapsido（remibrutinib）用于治疗H1抗组胺药控制不佳的成人症状性皮肤划痕症（SD）。这是该病获批的首个治疗药物。
症状性皮肤划痕症是最常见的慢性诱导性荨麻疹：皮肤被摩擦、抓挠或揉搓后就会起风团、发痒。超过一半的患者即使用H1抗组胺药仍控制不住症状。Rhapsido是一种口服的高选择性布鲁顿酪氨酸激酶（BTK）抑制剂，通过阻断组胺释放的通路起作用，剂量为25毫克、每日两次。
批准依据是三期RemIND试验中皮肤划痕症队列的数据，该队列纳入115名成人患者。第12周时，Rhapsido组有29.3%的患者风团完全消退，安慰剂组为14.0%（p=0.0229），而且第2周时就已观察到起效。诺华表示，该药在这一人群中的安全性与此前慢性自发性荨麻疹的数据一致，不需要常规实验室监测。
Rhapsido于2025年9月首先获批治疗慢性自发性荨麻疹（CSU），如今成为唯一同时获批用于这两种最常见慢性荨麻疹的处方药。诺华美国公司总裁Victor Bultó说：「今天的批准对皮肤划痕症患者是一个重要里程碑。」
FDA Approves Rhapsido as the First Treatment for Symptomatic Dermographism
Novartis announced in East Hanover, New Jersey, on October 7 that the U.S. Food and Drug Administration has approved Rhapsido (remibrutinib) as the first treatment for adults with symptomatic dermographism (SD) whose disease is inadequately controlled by H1 antihistamines.
Symptomatic dermographism is the most prevalent type of chronic inducible urticaria: everyday skin friction, scratching or rubbing triggers hives and itching. More than 50 percent of patients remain symptomatic despite taking H1 antihistamines. Rhapsido is an oral, highly selective Bruton's tyrosine kinase (BTK) inhibitor that blocks the pathway involved in the release of histamine, a key driver of hives and swelling. It is taken as a 25 mg tablet twice daily.
The approval is based on the SD cohort of the Phase III RemIND trial, which enrolled 115 adults who remained symptomatic on second-generation H1 antihistamines. At Week 12, 29.3 percent of patients treated with Rhapsido achieved complete resolution of hives compared with 14.0 percent on placebo (p=0.0229), with responses seen as early as Week 2. Novartis said the safety profile in SD was consistent with its experience in chronic spontaneous urticaria, with no routine lab monitoring required.
Rhapsido was first approved in September 2025 for chronic spontaneous urticaria (CSU) and is now the only prescription treatment approved in the United States for both of the two most common forms of chronic hives. "Today's approval marks an important milestone for people living with SD," said Victor Bultó, President, US, at Novartis.
来源：GSM·美国（原文链接）
图片来源：皮肤划痕性荨麻疹的风团（资料图）。JAguayo18 摄，CC BY-SA 4.0，经 Wikimedia Commons。 / Wheals of symptomatic dermographism (file photo). Photo by JAguayo18, CC BY-SA 4.0, via Wikimedia Commons.
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