Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) (chenodeoxycholic acid)
OrphanExceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- chenodeoxycholic acid
- Company
- Leadiant Biosciences Ireland Limited
- Status
- Authorised
- Therapeutic area
- Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
- CHMP opinion
- Thu 21 Jul 2016
- EU approval
- Mon 10 Apr 2017
- Designations
- Orphan, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/004061
- ATC
- A05AA01
- Official record
- www.ema.europa.eu
Indication
Chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years and adults.
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.