New form of glibenclamide gets EU nod for neonatal diabetes

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended a liquid formulation of glibenclamide (Amglidia) for the treatment of neonatal diabetes.

It said the sulphonylurea product would be available as an oral suspension (0.6 mg/ml and 6 mg/ml), to help avoid the off-label use of crushed glibenclamide tablets mixed with water.

“This practice can cause errors in the administration, potentially leading to a risk of under- or over-dosing. Amglidia’s formulation is meant to allow a more accurate dosing of glibenclamide, addressing a clear unmet medical need. Additionally, patients treated with Amglidia may not need to be treated with insulin or may need a smaller dosage,” the EMA said in a statement.

Amglidia is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children, the Agency said.

“Sulphonylureas like Amglidia have been shown to be effective in patients with mutations in the genes coding for the β-cell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.”

The EMA said the benefits with Amglidia are its ability to improve glycaemic control.

“Amglidia is a hybrid medicine of Daonil which has been authorised in the EU since 1 January 1969. Amglidia contains the same active substance as Daonil, but is approved for a different indication, and is available in a different formulation and strength. Studies have demonstrated the satisfactory quality, and relative bio-availability of Amglidia.”

The most common reported side effects are hypoglycaemia, transitory diarrhoea and abdominal pain.

Paediatric endocrinologist Professor Maria Craig, from the Children’s Hospital in Westmead, told the limbic the recommendation was ‘great news’.

“We use it also for infants and children with neonatal diabetes. Before the genetic mutations in the beta cell were discovered, which glibenclamide targets, we used to use insulin – and that is very, very tricky in a six-week-old.

“So it is being used globally already and good to see the indication is now approved in Europe.”



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