Waylivra (volanesorsen)
OrphanConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- volanesorsen
- Company
- Akcea Therapeutics Ireland Limited
- Status
- Authorised
- Therapeutic area
- Hyperlipoproteinemia Type I
- CHMP opinion
- Thu 28 Feb 2019
- EU approval
- Fri 03 May 2019
- Designations
- Orphan, Conditional, Additional monitoring
- Application
- EMEA/H/C/004538
- ATC
- C10AX18
- Official record
- www.ema.europa.eu
Indication
Waylivra is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.
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.