Eton Acquires U.S. Rights to Amglidia for Neonatal Diabetes
Eton acquires U.S. rights to Amglidia, targeting neonatal diabetes with plans for FDA approval by 2026.
Eton Pharmaceuticals has announced the acquisition of U.S. rights to Amglidia, an oral suspension of glyburide, for treating neonatal diabetes mellitus. This rare condition affects around 300 patients in the U.S., with no FDA-approved oral treatments currently available.
Amglidia, developed by AMMTeK and approved by the EMA in 2018, has been granted orphan drug designation by the FDA. Its efficacy and safety have been supported by a five-year post-approval study in Europe.
Eton plans to hold discussions with the FDA in early 2025 and submit a New Drug Application (NDA) by 2026. This move aligns with Eton’s focus on precision-dose pediatric treatments and aims to provide a critical therapy option for U.S. patients.
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