据媒体报道,今年赛诺菲对其度普利尤单抗(Dupixent,商品名:达必妥)在中国区的年销售额预期直指70亿元。 度普利尤单抗是一款靶向IL-4R的单抗药物,由赛诺菲与再生元合作开发。2017年3月,度普利尤单抗获FDA批准,成为首个治疗中重度特应性皮炎的生物...
而原因就是辉瑞的JAK制剂Xeljanz与传统的TNF抑制剂相比,与心脏相关的不良事件的风险增加。 受此次审查推迟影响的还有艾伯维Rinvoq的 2份sNDA (治疗中重度AD成人患者、治疗活动性银屑病关节炎成人患者)。 Rinvoq在2019年获得美国FDA批准,用于对甲氨蝶呤应答不足或不耐受(MTX-IR)的中度至重度活动性类风湿性关节炎(RA)...
In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with AD, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months to 5 years ...
2017年3月28日,美国FDA已批准该药物上市,用于治疗特应性皮炎。(新浪医药编译/David) 文章参考来源: 1、Sanofi: Dupixent® (dupilumab) showed positive topline results in two Phase 3 trials of patients with chronic rhinosinusitis with nasal polyps 2、https://www.accessdata.fda.gov/drugsatfda_docs/...
Dupixent Prescribing Information.https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761055s064lbl.pdf Read next How does the Dupixent Myway copay card work? With a Dupixent MyWay copay card, you may pay as little as $0 for out-of-pocket costs if you have commercial insurance. The...
AD-1434, an open-label extension study that enrolled 275 pediatric subjects 12 to 17 years of age treated with DUPIXENT ± TCS, 368 pediatric subjects 6 to 11 years of age treated with DUPIXENT ± TCS, and 180 pediatric subjects 6 months to 5 years of age treated with DUPIXENT ...
Dupixent Prescribing Information.https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761055s064lbl.pdf Further information Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Dupixent only for the indication prescribed. ...
想深入了解 DUPIXENT (DUPILUMAB) 的说明书详情?此页面详细了解REGENERON PHARMACEUTICALS 的BLA 761055申请,包括时间及说明书附件。上药智数据,查看完整信息,助力您的专业决策。
Regeneron Pharmaceuticals, Inc. REGN and partner Sanofi SNY announced that the FDA has accepted for Priority Review the supplemental biologics license application (sBLA) seeking label expansion of blockbuster drug Dupixent (dupilumab)
Meanwhile, Regeneron is working on expanding Eylea's label into additional indications. The FDA recently approved a 12-week dosing interval of Eylea injection in patients with wet AMD based on physician's assessment. Consequently, Eylea is now the only anti-VEGF drug for the treatment of wet AM...