Amglidia
Metabolic· 173 cited findings· 1 source document
Company: Ammtek
What the regulatory reviews say
Amglidia is an oral suspension containing glibenclamide, indicated for the treatment of neonatal diabetes mellitus in newborns, infants, and children. It is available in strengths of 0.6 mg/ml and 6 mg/ml. In the NEOGLI study, Amglidia demonstrated an HbA1c of 6.1% at Month 4. The median Tmax for glibenclamide suspensions was 0.5 hours, compared to 3.00 hours for crushed Daonil tablets. The mean Cmax for the 3 mg/5mL suspension was 206.93 ng/mL, while for crushed tablets it was 148.34 ng/mL. The relative bioavailability for the 3 mg/5 mL formulation versus Daonil was 121.6%.
Safety data from the NEOGLI study reported 7 hypoglycemic events with glibenclamide suspension, affecting 5 patients. In a broader context, hypoglycaemic episodes with sulfonylureas were observed in 5% of cases, compared to 2% with insulin. The maximum posology for the 0.6 mg/mL strength is 0.6 mg/kg/day. The regulatory procedure number for Amglidia is EMEA/H/C/004379/0000, and the applicant is Ammtek. The ATC Code for glibenclamide is A10BB01.
Key figures — cited to the source page
| HbA1c at M4 in NEOGLI study | 6.1 | Ammtek — Amglidia EMA EPAR public assessment report (EMEA/H/, p.35 |
| Median Tmax for glibenclamide suspensions | 0.5 | Ammtek — Amglidia EMA EPAR public assessment report (EMEA/H/, p.26 |
| Median Tmax for crushed Daonil tablet | 3.00 | Ammtek — Amglidia EMA EPAR public assessment report (EMEA/H/, p.26 |
| Relative bioavailability for 3 mg/5 mL formulation vs Daonil | 121.6 | Ammtek — Amglidia EMA EPAR public assessment report (EMEA/H/, p.27 |
| Hypoglycaemic episodes with SU | 5 | Ammtek — Amglidia EMA EPAR public assessment report (EMEA/H/, p.37 |
| Hypoglycemic events in NEOGLI study with glibenclamide suspension | 7 | Ammtek — Amglidia EMA EPAR public assessment report (EMEA/H/, p.43 |
| Maximum posology for 0.6 mg/mL strength | 0.6 | Ammtek — Amglidia EMA EPAR public assessment report (EMEA/H/, p.59 |
| Procedure Number | EMEA/H/C/004379/0000 | Ammtek — Amglidia EMA EPAR public assessment report (EMEA/H/, p.1 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.