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.

Share

The FDA has approved Redemplo (plozasiran) as a treatment for adults with familial chylomicronemia syndrome (FCS), a rare disorder that causes exceedingly high triglyceride levels and acute pancreatitis risks. This is the first approved small interfering RNA therapy for FCS, targeting apolipoprotein C-III to enhance triglyceride clearance. Administered subcutaneously every three months, Redemplo demonstrated a significant triglyceride reduction of approximately 80% in clinical trials. The therapy aims to address severe symptoms of FCS while presenting manageable adverse effects.

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

Related Content

Should SGLT-2 Inhibitors Be Continued After a UTI?

Patients with type 2 diabetes who developed urinary tract infections while taking sodium-glucose cotransporter-2 inhibitors faced higher heart and kidney risks.

Can SGLT-2 Inhibitors Shield Against Autoimmune Disease?

Researchers found sodium-glucose cotransporter-2 inhibitors lowered autoimmune rheumatic disease risk by 11% in adults with type 2 diabetes.

New Criteria, New Numbers on Obesity

A Lancet Commission definition integrating BMI with anthropometric measures increased obesity prevalence by ~60% in a major US cohort, identifying previously unrecognized high-risk patients while introducing distinct clinical phenotypes.