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Ionis 12-Month FCS Data Position Olezarsen For Near-Term Filing

 
• By Joseph Haas

Showing its antisense drug can reduce triglycerides and risk of acute pancreatitis in familial chylomicronemia syndrome, Ionis plans to file olezarsen for approval soon, hoping for accelerated approval.

Ionis's 12-month data strengthen rationale for olezarsen in FCS

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

  • 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.

The data presented on 7 April at the ACC annual meeting in Atlanta built upon topline data from the 66-patient...

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