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Johnson & Johnson Announces TREMFYA Demonstrates Results Across Biologic-Naïve And Biologic-Refractory Patients In Crohn's Disease And Ulcerative Colitis

Johnson & Johnson Announces TREMFYA Demonstrates Results Across Biologic-Naïve And Biologic-Refractory Patients In Crohn's Disease And Ulcerative Colitis

Johnson & Johnson宣佈TREMFYA在Crohn's病和潰瘍性結腸炎中展示出生物藥物未曾接受和生物藥物難治患者的結果
Benzinga ·  10/10 20:08

TREMFYA is now U.S. FDA-approved for ulcerative colitis and under review for Crohn's disease

TREMFYA現已獲得美國FDA批准用於潰瘍性結腸炎,並正在審查用於克羅恩病

TREMFYA is the only IL-23 inhibitor to demonstrate superiority to ustekinumab in the overall population of patients with Crohn's disease, inclusive of those who are biologic-naïve and biologic-refractory

TREMFYA是唯一一種在克羅恩病患者整體人群中顯示優越性優於ustekinumab的IL-23抑制劑,包括那些對生物製劑及地塞米松無效的患者

Ninety percent more biologic-naïve patients and three times more biologic-refractory patients with ulcerative colitis achieved endoscopic remission with TREMFYA

使用TREMFYA的生物製劑原發性患者中,潰瘍性結腸炎患者達到內鏡緩解的比例增加了九成,而生物製劑難治性患者的比例增加了三倍

VIENNA, Austria, Oct. 10, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced TREMFYA (guselkumab) data in both Crohn's disease (CD) and ulcerative colitis (UC) showing high rates of endoscopic remission in both biologic-naïve and biologic-refractory patients (including UC patients refractory to JAK inhibitors), indicating a normal appearance of intestinal mucosa.1,2 These subgroup analyses are from pooled data from the Phase 3 GALAXI 2 & 3 studies of TREMFYA in adults with moderately to severely active CD and the Phase 3 QUASAR maintenance study of TREMFYA in adults with moderately to severely active UC. These findings are among 19 Johnson & Johnson abstracts being presented at the United European Gastroenterology (UEG) Week 2024. TREMFYA is under review for the treatment of adults with moderately to severely active UC and CD by the European Medicines Agency (EMA).

維也納,奧地利,2024年10月10日 /美通社/ - 強生公司(紐交所:JNJ)今天宣佈TREMFYA(guselkumab)在克羅恩病(CD)和潰瘍性結腸炎(UC)中的數據顯示,對於生物製劑原發性患者和生物製劑難治性患者(包括對JAk抑制劑難治性的UC患者),內鏡緩解率高,表現爲腸粘膜正常。這些亞組分析來自TREMFYA在成年人中進行的3期GALAXI 2和3克羅恩病活動性較中度至重度患者的研究數據,以及TREMFYA在成年人中進行的3期QUASAR維持療法研究的潰瘍性結腸炎患者的數據。這些發現是約翰遜約翰遜公司在2024年歐洲消化病學協會週上提交的19篇摘要之一。TREMFYA正在接受歐洲藥品管理局(EMA)審查,用於對於活動性中度至重度的UC和CD患者治療。

譯文內容由第三人軟體翻譯。


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