Arrowhead Pharmaceuticals Receives the US FDA’s Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)
Shots:
- The US FDA has approved Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS; US availability is expected by year-end
- Approval was based on the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts could join a 2-part extension period where all receive Redemplo after completing randomization
- Trial met its 1 & key 2EPs, with reductions in TGs & APOC3. Redemplo (25mg) showed an -80% median TG reduction vs -17% in the pooled PBO group & demonstrated a lower numerical rate of acute pancreatitis; data was published in The NEJM& Circulation, & presented at ESC’24 & AHA’24
Ref: Businesswire | Image: Arrowhead | Press Release
Related News:- Arrowhead Enters a ~$2.2B Deal with Novartis for ARO-SNCA and TRiM-Based Therapies to Treat Neurodegenerative Diseases
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