By Colin Kellaher
Ionis Pharmaceuticals on Tuesday said a Phase 3 study of its olezarsen drug candidate met its key goals in the rare genetic disorder familial chylomicronemia syndrome, paving the way for planned regulatory filings.
The Carlsbad, Calif., pharmaceutical company said the study met its primary efficacy endpoint, with a statistically significant reduction in triglyceride levels with the olezarsen 80-milligram monthly dose at six months compared to placebo, and that triglyceride lowering continued to improve at 12 months.
Ionis said olezarsen 80-milligram also showed a 100% reduction in acute pancreatitis events compared to placebo, a key secondary endpoint.
Ionis said it plans to file early next year for U.S. Food and Drug Administration and European Union approval for olezarsen, adding that a green light would make olezarsen the first available treatment in the U.S. for familial chylomicronemia syndrome, which can lead to acute, potentially fatal pancreatitis attacks.
Write to Colin Kellaher at [email protected]
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