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September 16, 2025
財經

禮來減肥藥有望年底前獲美FDA批准

食品藥品監督管理局(FDA)近期推出了一項 1-2 個月的快速審查流程,禮來(Eli Lilly)的實驗性減肥藥有望通過該流程獲得加速審批。

分析師推測,這款名為奧福格列酮(orforglipron)的藥物具備成為獲批候選藥物的潛力,原因包括兩點:一是價格高昂的注射類減肥藥正帶來日益沈重的成本負擔,二是禮來公司正在擴大其美國本土產能 , 而這兩項議題均為川普政府的重點關注事項。

高盛近期估算,若奧福格列酮能比預期提前一個季度上市,將為禮來公司額外帶來 10 億美元營收。

今年 7 月,FDA 詳細公布了新推出的「局長級國家優先憑證」(Commissioner‘s National Priority Voucher)相關條款。

根據該條款,符合特定標準的實驗性藥物可在 1-2 個月內完成審批,而 FDA 常規審查流程通常需要 10 個月。

全美約 40% 的成年人口存在肥胖問題,而雇主與健康保險公司均表示,此類藥物價格高昂的問題極待解決。

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