Tryngolza (olezarsen)
- Region
- 🇪🇺 EU
- Active substance
- olezarsen
- Company
- Swedish Orphan Biovitrum AB (publ)
- Status
- Authorised
- Therapeutic area
- Hyperlipoproteinemia Type I
- CHMP opinion
- Thu 24 Jul 2025
- EU approval
- Wed 17 Sep 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006477
- ATC
- C10AX
- Official record
- www.ema.europa.eu
Indication
Tryngolza is indicated as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS).
Regulatory milestones
TRYNGOLZA: PDUFA target action date (severe hypertriglyceridemia (sHTG))
Ionis Pharmaceuticals Inc (IONS); olezarsen; sNDA; status: set; "…Olezarsen on track to launch this year as a transformational medicine for severe hypertriglyceridemia (sHTG), assuming approval o sNDA accepted by the FDA for Priority Review for the treatment of sHTG with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026 o The European Medicines Agency…"; filed 2026-04-29 · source
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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.