United Therapeutics: исследование фазы 3 TETON-1 по ИЛФ достигло первичной конечной точки

TETON-1 met its primary endpoint of absolute FVC change at 52 weeks with a 130.1 mL treatment effect over placebo (p<0.0001). The company plans to file a supplemental NDA by end of summer 2026 seeking IPF label expansion for nebulized Tyvaso, with priority review requested.

Ключевые факты

Подано: 30 мар. 2026 г., 11:00
Событие: Предварительные результаты
Направление: Положительное
Компания: UTHRUnited Therapeutics
Актив: treprostinil
Источник: SEC 8-K
Достоверность: Подтверждено
размер исследования: 598 пациентов
длительность исследования: 52 недели
абсолютное изменение ФЖЁЛ: 130.1 мл (оценка H-L, 95% ДИ 82.2-178.1 мл; p<0.0001)
интегрированное изменение ФЖЁЛ: 111.8 мл (оценка H-L, 95% ДИ 79.7-144.0; p<0.0001)

Выдержка из источника

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

SEC 8-K