美国食品和药物管理局批准了内拉多米拉斯用于慢性肺纤维化,试验显示肺功能下降速度减慢. The FDA approved nerandomilast for progressive pulmonary fibrosis, showing slowed lung function decline in trials.

美国FDA已批准使用内拉多米拉斯 (JASCAYD) 治疗渐进性肺纤维化 (PPF),这是一种罕见的,危及生命的肺病,影响多达10万美国人,与自身免疫性疾病或过敏性肺炎等疾病有关. The U.S. FDA has approved nerandomilast (JASCAYD) for progressive pulmonary fibrosis (PPF), a rare, life-threatening lung disease affecting up to 100,000 Americans, linked to conditions like autoimmune disorders or hypersensitivity pneumonitis. 基于第三期纤维化酶-ILD试验的批准显示，nerandomilast显著减缓了肺功能下降，18毫克和9毫克剂量下调整平均强制肺活量分别降低为-86 mL和-69 mL，而安慰剂组为-152 mL。 The approval, based on the Phase III FIBRONEER-ILD trial, shows nerandomilast significantly slowed lung function decline compared to placebo, with adjusted mean forced vital capacity reductions of -86 mL and -69 mL at 18 mg and 9 mg doses, respectively, versus -152 mL in the placebo group. 虽然没有观察到急性恶化、住院或死亡明显减少,但该药物显示出一种有利的安全特征,腹泻是最常见的副作用。 While no significant reduction in acute exacerbations, hospitalizations, or death was observed, the drug demonstrated a favorable safety profile, with diarrhea being the most common side effect. 这标志着在2025年核准病原性肺纤维化后,为PPFP批准的第一个PDE4B优惠抑制剂和第二个神经内分泌酶抑制剂。 This marks the first preferential PDE4B inhibitor approved for PPF and the second indication for nerandomilast, following its 2025 approval for idiopathic pulmonary fibrosis.