Kanuma (sebelipase alfa)
OrphanAccelerated assessmentAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- sebelipase alfa
- Company
- Alexion Europe SAS
- Status
- Authorised
- Therapeutic area
- Lipid Metabolism, Inborn Errors
- CHMP opinion
- Thu 25 Jun 2015
- EU approval
- Fri 28 Aug 2015
- Designations
- Orphan, Accelerated assessment, Additional monitoring
- Application
- EMEA/H/C/004004
- ATC
- A16
- Official record
- www.ema.europa.eu
Indication
Kanuma is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase (LAL) 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.