Deucravacitinib

Sotyktu has five years of clinical safety and efficacy data in patients with moderate-to-severe plaque psoriasis. Credit: 89stocker / Shutterstock.com. Bristol Myers Squibb (BMS) has received the US Food and Drug Administration (FDA) approval for Sotyktu (deucravacitinib), an oral selective tyrosine kinase 2 (TYK2) inhibitor, to treat adults with active psoriatic arthritis (PsA). This marks the first FDA approval of a TYK2 inhibitor specifically for this indication. The regulator granted this approval following findings from the pivotal POETYK PsA-I and POETYK PsA-II Phase III studies, which assessed the safety and efficacy of once-daily 6mg Sotyktu in adults with active PsA. Both trials showed notable improvements in disease activity, with the primary endpoint assessed by the ACR20 and minimal disease activity (MDA) response serving as a key secondary endpoint. Additional endpoints included ACR50 and ACR70. The most common adverse reactions reported included acne, folliculitis, increased blood creatine phosphokinase, herpes simplex, mouth ulcers, and upper respiratory infections. The clinical programme included two multi-centre, double-blind, placebo-controlled, randomised studies: POETYK PsA-I with 670 patients who had not previously received biologic disease-modifying antirheumatic drugs, and POETYK PsA-II with 624 patients who were either naïve to such treatments or had been treated with tumour necrosis factor alpha inhibitors. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Both trials included a 52-week treatment period and assessed the proportion of participants achieving an ACR20 response at week 16. Sotyktu was first approved by the FDA in 2022 for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Since then, global regulatory authorities have granted approvals for this indication. Sotyktu has five years of clinical safety and efficacy data in patients with moderate-to-severe plaque psoriasis. Bristol Myers Squibb cardiovascular and immunology commercialisation senior vice-president Al Reba said: “Today’s announcement marks the introduction of a new, differentiated option to treat adults with active psoriatic arthritis. “This latest approval of Sotyktu confirms its important role in managing both skin and joint symptoms of psoriatic disease and is a key milestone as we continue to explore its development in diseases that have limited or no treatment options.” Last month, BMS reported full-year 2025 revenues of $48.2bn, essentially flat compared with $48.3bn in 2024.

当地时间 3 月 6 日，百时美施贵宝（BMS）宣布，美国 FDA 已批准氘可来昔替尼（Deucravacitinib）的一项新适应症上市，用于治疗活动性银屑病关节炎。氘可来昔替尼是全球首个获批的 TYK2 变构抑制剂，此前已获 FDA 批准用于成人斑块状银屑病，本次获批使其成为了首个治疗银屑病关节炎的 TYK2 抑制剂。 截图来源：BMS 官网 氘可来昔替尼（Deucravacitinib）是一款酪氨酸激酶 2（TYK2）抑制剂，通过选择性靶向 TYK2 抑制 IL-23、IL-12 和 IFN 的信号传导，而这些细胞因子都是参与多种免疫介导疾病发病机制的关键细胞因子。 氘可来昔替尼通过与 TYK2 的调节结构域结合实现高度选择性，促成对 TYK2 及其下游功能的变构抑制。在生理浓度范围内，该产品选择性地抑制 TYK2，且在治疗剂量下不会抑制 JAK1、JAK2 或 JAK3。 本次新适应症的获批得到了关键性试验 POETYK PsA-1 和 POETYK PsA-2 的积极结果支持，这两项试验评估了氘可来昔替尼对活动性银屑病关节炎成人患者的疗效和安全性。 结果显示，这两项试验均达到了主要终点，与安慰剂组相比，接受氘可来昔替尼治疗的患者在治疗 16 周后达到 ACR20 缓解（疾病体征和症状改善至少 20%）的比例显著更高。POETYK PsA-2 的研究数据报告了 52 周治疗的结果，表明临床缓解在第 16 周至第 52 周期间得到改善并得以维持。 截图来源：BMS 官网 在活动性银屑病关节炎患者中观察到的氘可来昔替尼总体安全性与斑块状银屑病患者的安全性基本一致。 小结 氘可来昔替尼于 2022 年 9 月首次获批，是全球首个获批的 TYK-2 变构抑制剂。此前，该药已在美国、欧盟、日本、中国获批上市，用于治疗成人斑块状银屑病。2025 年，氘可来昔替尼全球销售额达 2.91 亿美元，同比增长 18.29%。 截图来源：Insight 数据库 Insight 数据库显示，除了斑块状银屑病和活动性银屑病关节炎以外，氘可来昔替尼还被开发用于干燥综合征（临床 III 期）、系统性红斑狼疮（临床 III 期）等适应症。这意味着氘可来昔替尼的销售额在未来还有持续的增长空间。 扫描二维码添加 「小音」，回复口令 新药获批，即可获得 Insight 整理的 2026 年全球新药获批上市资源大礼包👇（每月初更新一次，目前更新至 2 月）。 封面来源：企业Logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。 编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn