Redemplo OK’d for Cutting High Triglycerides in Rare Disorder

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.