The European Medicines Agency (EMA) have approved Amring's glibenclamide, brand name Amglidia, for the treatment for neonatal diabetes.
Neonatal diabetes is a disease of early infancy due to genetic mutations which result in failure of insulin secretion.
The prevalence of neonatal diabetes is less than 0.02 per 10,000 individuals in the EU and should be considered as an extremely rare disorder of genetic origin which cannot be prevented.
Amglidia is a liquid formulation of glibenclamide.
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About Amglidia (source EMA)
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).
In many newborn babies with neonatal diabetes, the cells in the pancreas produce insulin but they are not able to release it into the blood to control the level of blood glucose. The lack of insulin in the blood causes symptoms of diabetes.
The active substance in Amglidia, glibenclamide, is a diabetes medicine that belongs to the class of sulfonylureas. It works on insulin-producing cells in the pancreas and attaches to channels on their surface called KATP channels, involved in triggering the release of insulin. By attaching to these channels, glibenclamide restores the cells`ability to release insulin into the blood, reducing the symptoms of diabetes.
Amglidia was first made available in the EU in 2018. It is manufactured by Amring.
European Medicines Agency website page for Amglidia
Links available in External Resources
EMA product information about Amglidia
Reporting of suspected adverse reactions
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