<p>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.</p><p>Amglidia contains the active substance glibenclamide.</p><p>Neonatal diabetes is rare, and Amglidia was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 15 January 2016.</p><p>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).</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Amglidia is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children.</p> <p>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.</p> </div>
Therapeutic Area (MeSH)
ATC Code
A10BB01
ATC Item
N/A
Pharmacotherapeutic Group
Drugs used in diabetes
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| glibenclamide | N/A | glibenclamide |
EMA Name
Amglidia
Medicine Name
Amglidia
Aliases
N/ANo risk management plan link.