Eton Pharmaceuticals, Inc. has announced the acquisition of U.S. rights to Amglidia (glyburide oral suspension), also known as glibenclamide in Europe, from AMMTeK for the treatment of neonatal diabetes mellitus. This strategic move aims to address the significant unmet need for FDA-approved oral treatments for this rare condition affecting approximately 300 patients in the United States.
Addressing Unmet Needs in Neonatal Diabetes
Currently, no FDA-approved oral treatments exist for neonatal diabetes mellitus in the U.S. Patients often rely on compounded products or off-label use of homemade suspensions. Amglidia, already approved by the European Medicines Agency (EMA) and commercially available in Europe since 2018, offers a proprietary, patented liquid formulation specifically designed for this patient population.
Sean Brynjelsen, CEO of Eton Pharmaceuticals, stated, "This exciting transaction adds another attractive, patented product candidate to our growing pediatric endocrinology portfolio... Amglidia has been used successfully to treat European patients for years, and families and pediatric endocrinologists have expressed to us the significant need for this treatment in the United States."
Regulatory Pathway and Clinical Data
Amglidia has been granted Orphan Drug Designation by the U.S. FDA. AMMTeK has conducted a post-approval study tracking five years of real-world safety and efficacy data in European patients. Eton plans to leverage this data to support its New Drug Application (NDA) submission. The company anticipates holding a meeting with the FDA in the first quarter of 2025 and submitting the NDA in 2026.
Strategic Fit for Eton Pharmaceuticals
The acquisition of Amglidia aligns with Eton's focus on developing and commercializing treatments for rare diseases, particularly in pediatric endocrinology. Eton currently has five commercial rare disease products, including ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone, and three additional product candidates in late-stage development.
