原始来源记录
决策级FDA 说明书更新
Incyte：FDA批准Opzelura sNDA用于儿童特应性皮炎
FDA批准了Opzelura（ruxolitinib乳膏）的补充NDA，用于短期和非连续慢性治疗非免疫功能低下、2岁及以上轻度至中度特应性皮炎患者。扩展标签现已涵盖疾病未得到局部处方疗法良好控制或不推荐使用此类疗法的≥2岁儿科患者。
关键事实
- 申报时间
- 2025年10月28日 11:04
- 事件
- FDA 说明书更新
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
EX-99.1 2 incy-q32025xexx991.htm EX-99.1 Document Exhibit 99.1 FOR IMMEDIATE RELEASE Incyte Reports Third Quarter 2025 Financial Results and Provides Business Updates Total revenues of $1.37 billion in the third quarter of 2025, reflecting 20% growth compared to the third quarter of 2024 Jakafi ® (ruxolitinib) net product revenue of $791 million, an increase of 7% compared to the same period in 2024 Opzelura ® (ruxolitinib) cream net product revenue of $188 million, an increase of 35% compared to the prior year period Hematology-Oncology portfolio net product revenues of $171 million, including Niktimvo ™ (axatilimab-csfr) net revenue of $46 million Raises 2025 full year net product revenue guidance to $4.23 - $4.32 billion Conference Call and Webcast Scheduled Today at 8:00 a.m. ET WI