Arrowhead's REDEMPLO Nears EU Approval for Rare Triglyceride Disorder

Event summary

  • Arrowhead's REDEMPLO (plozasiran) received a positive CHMP opinion for EU approval in treating familial chylomicronemia syndrome (FCS).
  • The European Commission is expected to issue a decision on REDEMPLO’s Marketing Authorization in Q2 2026.
  • REDEMPLO is the first siRNA medicine authorized in the EU for both genetically confirmed and clinically diagnosed adult patients with FCS.
  • The CHMP positive opinion was supported by clinical data from the Phase 3 PALISADE study, which demonstrated significant reductions in triglycerides and apoC-III.

The big picture

Arrowhead's positive CHMP opinion for REDEMPLO marks a significant milestone in the treatment of familial chylomicronemia syndrome (FCS), a rare and underdiagnosed condition. This approval, if granted by the European Commission, will position Arrowhead as a leader in RNA interference therapies targeting metabolic disorders. The company's proprietary TRiM™ platform enables targeted siRNA treatments, potentially expanding into other disease areas with high unmet medical needs.

What we're watching

Regulatory Timing
Whether the European Commission will approve REDEMPLO by Q2 2026 as expected.
Market Expansion
How Arrowhead plans to increase global access to REDEMPLO beyond Europe, including ongoing regulatory reviews in other regions.
Clinical Efficacy
The long-term impact of REDEMPLO on reducing acute pancreatitis incidents and improving patient outcomes in FCS.