BridgeBio Pharma Says FDA Has Granted Breakthrough Therapy Designation To Oral Infigratinib Under Development For Children With Achondroplasia
BridgeBio Pharma Says FDA Has Granted Breakthrough Therapy Designation To Oral Infigratinib Under Development For Children With Achondroplasia
bridgebio pharma表示，FDA已经授予其针对儿童骨发育不良症（Achondroplasia）正在研发的口服Infigratinib药物突破性疗法认定。
Breakthrough Therapy Designation is designed to expedite the development and regulatory review of drugs in the U.S. that meet stringent criteria.
突破性疗法认定旨在加速符合严格标准的药物在美国的开发和审评过程。
Drugs qualifying for this Designation must show preliminary clinical evidence that the drug may demonstrate a substantial improvement on clinically significant endpoints over available therapies.
符合该认定条件的药物必须展示初步临床证据，证明该药物在临床显著终点上可能比现有治疗方法有显著改善。
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