Ionis Reports the CHMP’s Positive Opinion on Tryngolza for Familial Chylomicronemia Syndrome
Shots:
- The CHMP has recommended Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome; EC’s decision is expected in Q4’25
- Opinion was based on P-III (Balance) trial assessing (Q4W) vs PBO, which showed reduced triglyceride levels at 6mos., sustained through 12mos., with decrease in acute pancreatitis events over 12mos.; data was published in The NEJM
- Tryngolza is also being evaluated in the P-III (CORE & CORE2) trials for sHTG, with data expected in Q3’25
Ref: Ionis| Image: Ionis | Press Release
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