Pombiliti (cipaglucosidase alfa)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- cipaglucosidase alfa
- Company
- Amicus Therapeutics Europe Limited
- Status
- Authorised
- Therapeutic area
- Glycogen Storage Disease Type II
- CHMP opinion
- Thu 15 Dec 2022
- EU approval
- Mon 20 Mar 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005703
- ATC
- A16AB
- Official record
- www.ema.europa.eu
Indication
Pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset Pompe disease (acid ?-glucosidase [GAA] deficiency).
Regulatory milestones
No milestones recorded in the last year.
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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.