VYVGART显示,眼部心血管瘤眼部症状显著改善,计划扩大FDA标签。 VYVGART showed significant improvement in eye symptoms for ocular myasthenia gravis, with plans to expand its FDA label.

Argenx报告说,ADAPT OCULUS试验产生了第3阶段的积极结果,表明VYVGART在眼科眼科眼科腺瘤中明显改善了眼部症状,达到了其主要终点,与安慰剂相比,在统计学上有了显著改善。 Argenx reported positive Phase 3 results from the ADAPT OCULUS trial, showing VYVGART significantly improved eye symptoms in ocular myasthenia gravis, meeting its primary endpoint with a statistically significant improvement over placebo. 该公司计划向林业发展局提交一份生物许可证补充申请,以扩大VYVGART的标签,使之包括眼部MG,预计2026年5月10日为血清普遍通用MG,PDUFA日期。 VYVGART继续出现强劲的商业增长,2025年全球治疗了近19,000名病人,4,700多个处方,70%的新病人不再接受口服疗法。 The company plans to file a supplemental Biologics License Application with the FDA to expand VYVGART’s label to include ocular MG, with a May 10, 2026, PDUFA date expected for seronegative generalized MG. VYVGART continues to see strong commercial growth, with nearly 19,000 patients treated globally in 2025, over 4,700 prescribers, and 70% of new patients switching from oral therapies. 该公司实现了第一个全年营业利润,2025年净销售额达41.5亿美元,第四季度销售额增至13亿美元。 The company achieved its first full-year operating profitability, with 2025 net sales reaching $4.15 billion and fourth-quarter sales rising to $1.3 billion.