根据临床试验数据,FDA 批准武田的 EOHILIA 作为美国 11 岁以上嗜酸性粒细胞性食管炎的首个口服治疗药物。 FDA approves Takeda's EOHILIA as first oral treatment for eosinophilic esophagitis in US aged 11+, based on clinical trial data.
FDA 批准武田的 EOHILIA(布地奈德口服混悬液),这是美国第一个用于治疗 11 岁及以上个体嗜酸性粒细胞性食管炎 (EoE) 的口服药物。 FDA approves Takeda's EOHILIA (budesonide oral suspension), the first oral treatment in the U.S. for eosinophilic esophagitis (EoE) in individuals 11 years and older. 该药物将于 2 月底以 2mg/10mL 单剂量棒状包装上市。 The drug will be available by the end of February in 2mg/10mL single-dose stick packs. FDA 的批准基于两项为期 12 周的临床试验的数据,证明了其有效性和安全性。 The FDA's approval is based on data from two 12-week clinical trials demonstrating efficacy and safety. 武田目前正在评估此次批准对其截至 2024 年 3 月 31 日的财年的财务影响。 Takeda is currently assessing the financial impact of this approval on its fiscal year ending March 31, 2024.