Basic Information
Amglidia
Regulatory Information
EMEA/H/C/004379
May 24, 2018
December 14, 2017
8
December 6, 2023
Company Information
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Amglidia is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children. Sulphonylureas like Amglidia have been shown to be effective in patients with mutations in the genes coding for the ?-cell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.
Overview Summary
Amglidia is a medicine used to treat newborns and children with neonatal diabetes, a form of diabetes that occurs in the first 6 months of life and that requires treatment with insulin. Amglidia was shown to be effective in patients with whose disease was caused by certain genetic mutations. Amglidia contains the active substance glibenclamide. Neonatal diabetes is rare, and Amglidia was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 15 January 2016. Amglidia is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but is available in a different formulation. While the reference medicine Daonil is given as tablets, Amglidia is available as a liquid (suspension).