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# Redemplo OK’d for Cutting High Triglycerides in Rare Disorder
- URL: https://www.fdaweb.com/redemplo-okd-for-cutting-high-triglycerides-in-rare-disorder/
- Published: 2025-11-18T12:00:00.000Z
- Updated: 2026-09-14T15:26:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160238

FDA has approved an Arrowhead Pharmaceuticals NDA for Redemplo (plozasiran) for reducing dangerously high triglyceride levels in adults with familial chylomicronemia syndrome (FCS), a rare genetic disorder that can trigger life-threatening pancreatitis. Redemplo is approved as an adjunct to a very low-fat diet for adults with FCS, a condition that impairs the body’s ability to break down triglycerides.

The approval is based on data from a placebo-controlled trial of adults with genetically confirmed or clinically diagnosed FCS, according to FDA. Participants received either Redemplo 25 mg or placebo once every three months for a year. At month 10, median triglycerides fell 59% from baseline in the Redemplo group, a substantial reduction compared with placebo, it says.

FDA notes that the most common adverse events included hyperglycemia, headache, nausea, and injection-site reactions.