Redemplo

Opinion

EMA has issued an opinion on this medicine

plozasiran

Overview

On 23 April 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Redemplo, intended for the treatment of adults with familial chylomicronaemia syndrome (FCS).

The applicant for this medicinal product is Arrowhead Pharmaceuticals Ireland Limited.

Redemplo will be available as a 25 mg solution for injection in pre-filled syringes. The active substance of Redemplo is plozasiran, a small interfering RNA conjugated with N-acetylgalactosamine (ATC code: not yet assigned). Plozasiran selectively degrades the mRNA for apolipoprotein C3 (APOC3) in hepatocytes, resulting in reduced levels of hepatic and serum APOC3 protein. This, in turn, enhances the activity of lipoprotein lipase and hepatocyte uptake of triglyceride-rich lipoprotein remnants, leading to decreases in serum triglycerides.

The benefit of Redemplo is a reduction in the levels of fasting triglycerides compared with placebo, as observed in a phase 3, randomised, double-blind, placebo-controlled clinical study involving adults with FCS. The most common side effects with Redemplo are hyperglycaemia, headache, nausea and injection site reactions.

The full indication is:

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).

Treatment with Redemplo should be initiated and supervised by a physician experienced in the treatment of patients with FCS.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

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Note: This product was designated as an orphan medicine during its development. EMA has reviewed the information available to date and determined that the orphan designation should be maintained.

CHMP summary of positive opinion for Redemplo

Adopted Reference Number: EMA/CHMP/94677/2026

Product details

• Name of medicine:
  Redemplo
• Active substance:
  plozasiran
• International non-proprietary name (INN) or common name:
  plozasiran
• Therapeutic area (MeSH):
  Hyperlipoproteinemia Type I
• Anatomical therapeutic chemical (ATC) code:
  C10AX
• EMA product number:
  EMEA/H/C/006579
• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation applicant:
  Arrowhead Pharmaceuticals Ireland Limited
• Opinion adopted:
  23/04/2026
• Opinion status:
  Positive