Ionis Pharmaceuticals Inc. has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for its drug olezarsen, intended as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (sHTG). The designation is based on Phase 3 CORE and CORE2 studies, which showed olezarsen significantly reduced triglyceride levels and acute pancreatitis events compared to placebo. Ionis plans to submit a supplemental new drug application to the FDA by the end of the year.
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