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Ionis Reports P-III Study (Balance) Results of Olezarsen for Familial Chylomicronemia Syndrome

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Ionis Reports P-III Study (Balance) Results of Olezarsen for Familial Chylomicronemia Syndrome

Shots:

  • The P-III study evaluating olezarsen (80 or 50mg) vs PBO via SC inj., q4w for 53wks. in a ratio (1:1:1) in 66 patients aged ≥18yrs. The trial met its primary efficacy EPs with a reduction in triglyceride levels with olezarsen (80mg monthly dose) at 6mos.
  • Triglyceride lowering continued to improve at 12mos., 100% reduction in acute pancreatitis events & >75% in apoC-III. Dose-dependent effect with both study doses showed a reduction in pancreatitis
  • 50mg dose did not reach statistical significance at 6mos. on 1EPs of triglyceride-lowering & demonstrated a favorable safety & tolerability profile with no hepatic or renal toxicity events & no clinical platelet reductions. The company plans to file an NDA in early 2024 with the US FDA

Ref: PR Newswire | Image: Ionis

Related News:- Ionis Initiates P-III CORE Study of Olezarsen for the Treatment of Severe Hypertriglyceridemia

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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