Brineura (cerliponase alfa)
OrphanExceptional circumstancesAccelerated assessmentAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- cerliponase alfa
- Company
- BioMarin International Limited
- Status
- Authorised
- Therapeutic area
- Neuronal Ceroid-Lipofuscinoses
- CHMP opinion
- Fri 21 Apr 2017
- EU approval
- Tue 30 May 2017
- Designations
- Orphan, Exceptional circumstances, Accelerated assessment, Additional monitoring
- Application
- EMEA/H/C/004065
- ATC
- A16AB
- Official record
- www.ema.europa.eu
Indication
Brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency
Regulatory milestones
No milestones recorded in the last year.
Follow Brineura
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.