2026年3月18日 12:31 UTC / 路透社
作者:斯里帕娜·罗伊
2023年12月5日,美国纽约市纽约证券交易所(NYSE)外展示着强生公司的横幅。路透社/布伦丹·麦克德莫特 购买许可权,打开新标签页
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3月18日(路透社)——强生公司(JNJ.N,打开新标签页)周三表示,美国食品药品监督管理局已批准其口服银屑病药物,这为慢性自身免疫性疾病患者提供了更便捷的治疗选择。银屑病会导致皮肤出现瘙痒、鳞屑和发炎斑块。
该药物将帮助强生拓展银屑病市场,因其重磅炸弹级别的注射剂Stelara正面临低成本仿制药的日益激烈竞争。
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卫生监管机构批准该药物用于成人及12岁以上、体重至少40公斤的儿童患者的中重度斑块状银屑病治疗。
强生公司未立即回应路透社就定价和供应情况的置评请求。
该药物品牌名为Icotyde,将与百时美施贵宝(BMY.N,打开新标签页)的Sotyktu和艾伯维(ABBV.N,打开新标签页)的Skyrizi展开竞争。
华尔街分析师表示,强生的Icotyde具有“重磅炸弹潜力”,作为一种安全有效的口服药物,每日一次的用药方式可能会抢占显著的市场份额。
在两项晚期头对头试验中,该药物显示出比百时美施贵宝的Sotyktu更优的皮肤清除效果。
强生全球免疫学负责人大卫·李在决定公布前告诉路透社:“患者一直寻求完全的皮肤清除、良好的安全性以及每日一次服药的简便性。”
李表示:“我们认为Icotyde将成为银屑病患者的一线全身治疗药物。”
强生的口服药物与艾伯维的Skyrizi和强生自己的Tremfya类似,旨在阻断参与炎症反应的IL-23蛋白。该口服药物由强生与Protagonist Therapeutics(PTGX.O,打开新标签页)合作开发。
强生还在研究这种化学名为icotrokinra的药物用于溃疡性结肠炎、银屑病关节炎和克罗恩病的治疗。
报道:斯里帕娜·罗伊(班加罗尔);编辑:艾伦·巴罗纳和辛吉尼·甘古利
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US FDA approves J&J’s oral psoriasis pill
March 18, 2026 12:31 PM UTC / Reuters
By Sriparna Roy
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A Johnson & Johnson banner is displayed on the front of the New York Stock Exchange (NYSE) in New York City, in New York City, U.S., December 5, 2023. REUTERS/Brendan McDermid Purchase Licensing Rights, opens new tab
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March 18 (Reuters) – The U.S. Food and Drug Administration has approved Johnson & Johnson’s (JNJ.N), opens new tab oral pill for psoriasis, the company said on Wednesday, paving the way for a more convenient treatment option for patients with the chronic autoimmune condition that causes itchy, scaly, and inflamed patches of skin.
The drug will help J&J expand into the psoriasis market, as its blockbuster injectable Stelara comes under increasing competition from low-cost copycat drugs.
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The health regulator approved the drug for moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg.
The company did not immediately respond to Reuters’ requests for comment on pricing and availability.
The drug, branded as Icotyde, will compete with Bristol Myers Squibb’s (BMY.N), opens new tab Sotyktu and AbbVie’s (ABBV.N), opens new tab Skyrizi.
Wall Street analysts have said J&J’s Icotyde has “blockbuster potential” as a safe and effective oral, and that the once-daily medication could capture significant market share.
The drug has shown superior skin clearance compared to Bristol’s Sotyktu, in two late-stage head-to-head trials.
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Patients have been looking for complete skin clearance, a favorable safety profile, and the simplicity of a once-a-day pill, David Lee, J&J’s global head of immunology, told Reuters ahead of the decision.
“We see Icotyde as becoming the first-line systemic therapy for psoriasis patients,” said Lee.
J&J’s oral pill, like AbbVie’s Skyrizi and J&J’s own Tremfya, is designed to block a protein, IL-23, involved in inflammatory responses. The oral drug is developed in partnership with Protagonist Therapeutics (PTGX.O), opens new tab.
J&J is also studying the drug, chemically known as icotrokinra, for ulcerative colitis, psoriatic arthritis and Crohn’s disease.
Reporting by Sriparna Roy in Bengaluru; Editing by Alan Barona and Shinjini Ganguli
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