Eton Pharmaceuticals Has Acquired The Us Rights To Amglidia (Glyburide Oral Suspension, Known As Glibenclamide In Europe) For Neonatal Diabetes Mellitus From AMMTeK, Potential US Marketing Application Submission Expected In 2026
Eton Pharmaceuticals Has Acquired The Us Rights To Amglidia (Glyburide Oral Suspension, Known As Glibenclamide In Europe) For Neonatal Diabetes Mellitus From AMMTeK, Potential US Marketing Application Submission Expected In 2026
Eton Pharmaceuticals 已獲得 AMMTek 的美國產權，用於治療新生兒糖尿病的 Amglidia（甘露醇口服懸液，在歐洲稱爲格列本脲），預計將在 2026 年提交美國市場營銷申請。
- Amglidia is a proprietary, patented liquid product that was developed for the treatment of neonatal diabetes mellitus by AMMTeK, a French biotechnology company. The product was approved by the EMA in 2018.
- The product has already been granted Orphan Drug Designation by the U.S. FDA. Neonatal diabetes mellitus is a rare condition estimated to impact approximately 300 patients in the United States.
- Currently, there are no FDA-approved oral treatment options and as a result, U.S. patients frequently either rely on compounded products that are not FDA-approved or administer products off-label by making homemade suspensions.
- AMMTeK has conducted a post-approval study tracking five years of real-world safety and efficacy in European patients, which will be used to support Eton's NDA submission. Eton plans to hold a meeting with the FDA in the first quarter of 2025 and anticipates submitting an NDA for the product in 2026.
- Amglidia是一種專有的、受專利保護的液體產品，由法國生物技術公司AMMTek開發，旨在治療新生兒糖尿病。這款產品於2018年獲得了EMA的批准。
- 該產品已經獲得了美國FDA的孤兒藥資格認定。新生兒糖尿病是一種罕見的控件，預計在美國影響約300名患者。
- 目前，沒有FDA批准的口服治療期權，因此，美國患者通常依賴於未獲得FDA批准的合成產品，或者通過自制懸浮液來非標籤使用產品。
- AMMTek進行了一項批准後的研究，跟蹤歐洲患者五年的真實世界安全性和有效性，這將用於支持Eton的NDA提交。Eton計劃於2025年第一季度與FDA召開會議，並預計在2026年提交該產品的NDA。
譯文內容由第三人軟體翻譯。
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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