Neonatal diabetes is an ultra -raw disease.The EMA is approved to an oral glibenclamide formulation.
The Committee of Human Use Medicines of the EMA European Agency has issued a positive opinion about the Amplidia medicine (Glibenclamide, of AMMTEK Pharmaceuticals), for the treatment of neonatal diabetes mellitus and its use in newborns, babies and children.It is the previous step to the authorization of marketing by the European Commission.
Since neonatal diabetes is an extremely rare disease that is diagnosed in the first six months of life, the medication obtained the designation of orphan in January 2016. Amglidia is a new oral formulation of glibenclamide, an authorized drug for type 2 diabetes,specifically developed for pediatric population.It is a damage hybrid (from Sanofi), which has been in the European market since 1969. The dossier of application for hybrid authorization consists of preclinical data, rehearsals of the reference product and new data.
"Non -covered need"
EMA understands that the medicine "addresses a clear non -covered medical need."To treat neonatal diabetes insulin or glibenclamide tablets, which are chopped and mixed with water and are administered in a syringe, which implies a risk of administration errors, is used.