Neonatal diabetes mellitus affects an estimated 300 individuals in the US. Credit: July Semianovich/Shutterstock.

Eton Pharmaceuticals has acquired the US rights to Amglidia, a treatment developed for neonatal diabetes mellitus, from France-based biotechnology company AMMTeK.

Amglidia, also known as glibenclamide in Europe, is a patented liquid product and was approved by the European Medicines Agency in 2018.

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The move is set to align with Eton Pharmaceuticals’ focus on paediatric endocrinology.

The product also holds an orphan drug designation from the US Food and Drug Administration (FDA).

AMMTeK’s post-approval study, which includes five years of real-world data on efficacy and safety from European subjects, is set to back Eton Pharmaceuticals’ new drug application submission.

Eton Pharmaceuticals plans to meet with the FDA in the first quarter of 2025 and submit the NDA in 2026.

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Eton Pharmaceuticals CEO Sean Brynjelsen stated: “This exciting transaction adds another attractive, patented product candidate to our growing paediatric endocrinology portfolio.

“The product aligns with Eton’s expertise and wealth of experience in bringing to market liquid and precision dose formulations for paediatric patients. Currently, there are no FDA-approved oral treatments for neonatal diabetes mellitus.

“Amglidia has been used successfully to treat European patients for years, and families and paediatric endocrinologists have expressed to us the significant need for this treatment.”

Neonatal diabetes mellitus affects an estimated 300 individuals in the US.

Eton Pharmaceuticals acquired the US rights to PKU GOLIKE from Relief Therapeutics in March 2024.

PKU GOLIKE is a medical formula product for the dietary management of phenylketonuria (PKU), using patented Physiomimic technology.

In November 2021, the FDA approved Eton Pharmaceuticals and Azurity Pharmaceuticals’ Eprontia (topiramate) oral solution for seizures and migraine treatment.