Arrowhead Pharmaceuticals received FDA approval for REDEMPLO (plozasiran) to reduce triglycerides in adults with Familial Chylomicronemia Syndrome (FCS).
FCS is a rare disease affecting an estimated 6,500 people in the U.S. who face a substantially higher risk of pancreatitis due to extremely high triglyceride levels.
REDEMPLO is the first FDA-approved siRNA medicine for FCS patients, offering a new treatment option that can be self-administered at home.
FDA Approval of REDEMPLO
REDEMPLO (plozasiran) is the first and only FDA-approved medicine for genetically confirmed and clinically diagnosed FCS patients.
Phase 3 PALISADE Study Results
Positive results from the PALISADE study showed significant reduction in triglycerides and a lower incidence of acute pancreatitis compared to placebo.
Targeted RNAi Molecule Platform
REDEMPLO utilizes Arrowhead's proprietary TRiMTM platform, marking a major milestone for the company in commercial-stage development.
- The FDA approval of REDEMPLO marks a transformative milestone for Arrowhead Pharmaceuticals, offering new hope to FCS patients.
- With deep and durable reductions in triglycerides, REDEMPLO presents a promising treatment option for patients at risk of pancreatitis.
- Arrowhead's innovative TRiMTM platform opens up possibilities for addressing a wider range of diseases and changing more lives.
- The approval of REDEMPLO reflects a collaborative effort with input from patients and caregivers, emphasizing empathy-driven innovation in healthcare.
The approval of REDEMPLO represents a significant advancement in the treatment of familial chylomicronemia syndrome, providing a much-needed solution for patients facing high triglyceride levels and related risks.