Eton Pharmaceuticals, a US-based pharmaceutical company focused on rare diseases, has acquired the US rights to Amglidia (glyburide oral suspension) from French drugmaker AMMTeK.
Amglidia, also known as glibenclamide in Europe, is a patented liquid product that was developed for the treatment of neonatal diabetes mellitus.
The product has already received the US Food and Drug Administration (FDA) Orphan Drug Designation and the European Medicines Agency (EMA) approval in 2018.
Eton Pharmaceuticals CEO Sean Brynjelsen said: “This exciting transaction adds another attractive, patented product candidate to our growing paediatric endocrinology portfolio.
“In addition, the product aligns with Eton’s expertise and wealth of experience in bringing to market liquid and precision dose formulations for paediatric patients.”
“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 in the US.”
According to Eton, neonatal diabetes mellitus (NDM) is a rare disease that affects an infant’s ability to produce or use insulin, resulting in high blood sugar levels.
Currently, there are no FDA-approved oral treatment options for NDM, and US patients frequently depend on compounded products that are not FDA-approved.
Eton is preparing to hold a meeting with the FDA in the first quarter of 2025, with plans to submit a new drug application (NDA) for Amglidia in 2026.
AMMTeK has completed a post-approval study in European patients, to track five years of real-world safety and efficacy data, which will be used to support Eton’s NDA submission.
