Redemplo (plozasiran)
- Region
- 🇪🇺 EU
- Active substance
- plozasiran
- Company
- Arrowhead Pharmaceuticals Ireland Limited
- Status
- Authorised
- Therapeutic area
- Hyperlipoproteinemia Type I
- CHMP opinion
- Thu 23 Apr 2026
- EU approval
- Fri 19 Jun 2026
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/006579
- ATC
- C10AX
- Official record
- www.ema.europa.eu
Indication
Redemplo is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with familial chylomicronaemia syndrome (FCS) (see section 4.2 for patient selection criteria).
Regulatory milestones
Redemplo (plozasiran) approved in the EU
Marketing authorisation to Arrowhead Pharmaceuticals Ireland Limited; Orphan, Additional monitoring · source
Redemplo (plozasiran): CHMP positive opinion
Arrowhead Pharmaceuticals Ireland Limited; Orphan, Additional monitoring · source
FDA approves Redemplo (plozasiran sodium), a new medicine
Arrowhead; NDA219947; New molecular entity; solution · source
Same substance in other markets
- 🇺🇸 Redemplo Approved · Arrowhead
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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.