原始来源记录
决策级顶线结果
United Therapeutics：TETON-1 3期IPF试验达到主要终点
TETON-1达到主要终点，即52周绝对FVC变化，治疗效果比安慰剂高130.1 mL（p<0.0001）。公司计划在2026年夏季末提交补充NDA，申请将雾化Tyvaso的IPF适应症扩大，并请求优先审评。
关键事实
- 申报时间
- 2026年3月30日 11:00
- 事件
- 顶线结果
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- 试验规模
- 598名患者
- 试验时长
- 52周
- 绝对用力肺活量变化
- 130.1 mL（H-L估计值，95% CI 82.2-178.1 mL；p<0.0001）
- 综合用力肺活量变化
- 111.8 mL（H-L估计值，95% CI 79.7-144.0；p<0.0001）
来源摘录
EX-99.1 2 tm2610558d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 United Therapeutics Corporation Announces TETON-1 Pivotal Study of Tyvaso® Meets Primary Endpoint for Treatment of Idiopathic Pulmonary Fibrosis, Exceeding Impressive Treatment Effect Seen in TETON-2 Nebulized Tyvaso® (treprostinil) Inhalation Solution demonstrated superiority over placebo for the change in absolute forced vital capacity by 130.1 mL and reduced the risk of clinical worsening in patients with idiopathic pulmonary fibrosis, with positive results observed across all subgroups Integrated analyses of TETON-1 and TETON-2 showed statistically significant treatment effects across the primary and most secondary efficacy endpoints, reinforcing the robustness of the clinically meaningful results observed in each of the in
