Amglidia (glibenclamide)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- glibenclamide
- Company
- Ammtek
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus
- CHMP opinion
- Thu 14 Dec 2017
- EU approval
- Thu 24 May 2018
- Designations
- Orphan
- Application
- EMEA/H/C/004379
- ATC
- A10BB01
- Official record
- www.ema.europa.eu
Indication
Amglidia is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children. Sulphonylureas like Amglidia have been shown to be effective in patients with mutations in the genes coding for the ?-cell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.
Regulatory milestones
No milestones recorded in the last year.
Follow Amglidia
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.