Ammtek — Amglidia EMA EPAR public assessment report (EMEA/H/C/004379, 2018)

Ammtek · 2018 · EMA EPAR public assessment report

Report summary

This EMA report assesses Amglidia (glibenclamide oral suspension) for neonatal diabetes mellitus, replacing off-label crushed tablets with a compliant formulation. It details manufacturing, quality control, and non-clinical data. Clinical studies confirm higher bioavailability than tablets, requiring dose adjustments. Efficacy, supported by literature and the NEOGLI study, shows maintained glycemic control and significant HbA1c reductions when switching from insulin. Safety concerns include hypoglycemia, transitory transaminases, and neutropenia, but no increased severe hypoglycemia risk or long-term detrimental effects were observed. A risk management plan includes educational materials to prevent dosing errors and hypoglycemia due to multiple presentations, emphasizing correct syringe use and strength selection.

Key findings — cited to the page

Minimum production scale batches for validation	3	· p.16
Active substance	GLIBENCLAMIDE	Amglidia · p.2
Strength	6 mg/ml	Amglidia · p.2
Indication	treatment of neonatal diabetes mellitus, for use in newborns, infants and children	Amglidia · p.2
Pharmaceutical form	Oral suspension	Amglidia · p.2
Strength	0.6 mg/ml	Amglidia · p.2
ATC Code	A10BB01	Amglidia · p.2
Route of administration	Oral use	Amglidia · p.2
Orphan medicinal product designation number	EU/3/15/1589	Amglidia · p.7
Orphan medicinal product designation date	15 January 2016	Amglidia · p.7
Marketing authorisation application submission date	6 October 2016	Amglidia · p.7
Applicant	Ammtek	Amglidia · p.2

Source: Ammtek ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →