FDA & Government News

Plozasiran Wins FDA Nod for FCS

Arrowhead’s small interfering RNA therapy reduced triglycerides and lowered pancreatitis risk in the phase 3 PALISADE trial, providing a quarterly self-administered option for patients with familial chylomicronemia syndrome.

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7 Key Takeaways

  • 1

    Redemplo (plozasiran) approved by FDA for familial chylomicronemia syndrome.

  • 2

    First small interfering RNA therapy for this condition.

  • 3

    Targets apolipoprotein C-III to lower triglyceride levels.

  • 4

    Administered subcutaneously every three months.

  • 5

    Phase 3 PALISADE trial showed ~80% triglyceride reduction.

  • 6

    Support program 'Rely On REDEMPLO' to assist patients.

  • 7

    Anticipated availability in the US before year-end.

Original Source(s)

Plozasiran Wins FDA Nod for FCS

Arrowhead’s small interfering RNA therapy reduced triglycerides and lowered pancreatitis risk in the phase 3 PALISADE trial, providing a quarterly self-administered option for patients with familial chylomicronemia syndrome.

  • by Kathryn Wighton

  • November 18, 2025

  • 2 min

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