For familial chylomicronemia syndrome (FCS). NDA 219947, held by Arrowhead. Plozasiran Sodium.
As of Nov 13, 2026, NDA 219947 (Redemplo), held by Arrowhead, was first approved by FDA on Nov 18, 2025, with 0 approved supplements and 0 published complete response letters.
REDEMPLO is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 18, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| RedemploEQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) · solution;subcutaneous | Plozasiran Sodium | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
