原始来源记录
决策级FDA 批准
Ironwood：FDA批准LINZESS用于7岁及以上患者的IBS-C
FDA批准LINZESS（利那洛肽）用于治疗7岁及以上儿童的IBS-C，使其成为7-17岁年龄组中首个且唯一获批用于该适应症的处方药。此次标签扩展将该药的临床用途从先前的成人适应症扩大。批准被表述为2025年11月10日新闻稿中已完成的监管结果。
关键事实
- 申报时间
- 2025年11月10日 12:12
- 事件
- FDA 批准
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- 日历
- FDA 审批决定 (PDUFA) · 2026年5月24日 · 已批准
来源摘录
EX-99.1 2 tm2530577d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 FOR IMMEDIATE RELEASE Ironwood Pharmaceuticals Reports Strong Third Quarter 2025 Results; Raises Full Year 2025 Financial Guidance – LINZESS ® (Iinaclotide) U.S. net sales of $315 million in Q3 2025, an increase of 40% year-over-year; EUTRx demand growth increased 12% year-over-year – – GAAP net income of $40 million and adjusted EBITDA of $82 million in Q3 2025; ended Q3 2025 with $140 million in cash and cash equivalents – – Raises full-year 2025 LINZESS U.S. net sales guidance to $860 - $890 million; total revenue guidance to $290 - $310 million and adjusted EBITDA guidance to greater than $135 million – – FDA approves LINZESS as the first drug for the treatment of children 7 years and older with irritable bowel syndrome