regulatory
confidence high
sentiment positive
materiality 0.95
Arrowhead Pharmaceuticals Announces FDA Approval of REDEMPLO for Familial Chylomicronemia Syndrome
ARROWHEAD PHARMACEUTICALS, INC.
- REDEMPLO (plozasiran) approved by FDA as adjunct to diet to reduce triglycerides in adults with FCS.
- Phase 3 PALISADE study showed 80% median triglyceride reduction vs 17% placebo and lower acute pancreatitis incidence.
- REDEMPLO is first FDA-approved siRNA medicine for FCS, self-administered quarterly at home.
- Approximately 6,500 people in the U.S. live with genetic or clinical FCS.
- Arrowhead's first FDA-approved medicine marks transition to a commercial-stage company.