After reporting the full dataset from the Phase III BALANCE study of olezarsen in familial chylomicronemia syndrome (FCS) at the American College of Cardiology meeting, Ionis Pharmaceuticals, Inc. told an investor call on 8 April that it expects to file the ligand-conjugated antisense (LICA) candidate for US approval imminently, with approval possibly before the end of the year.
Key Takeaways
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Building on topline data reported last year, Ionis reveals that olezarsen reduces triglyceride levels and risk of pancreatitis over 12 months in a Phase III study.
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Ionis plans to file for FDA approval soon, hoping for accelerated approval and planning to bring the antisense drug to the US market itself
The data presented on 7 April at the ACC annual meeting in Atlanta built upon topline data from the 66-patient study reported by Ionis last September, which showed the higher of two doses of olezarsen tested, 80mg monthly, met the primary endpoint of reduction from baseline in triglyceride levels at six months compared to placebo. (Also see "Ionis Closer To First Wholly-Owned Drug Launch With Olezarsen Phase III Success" - Scrip, 27 September, 2023
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