Ionis: FDA Grants Breakthrough Therapy Designation To Olezarsen

(RTTNews) - Ionis Pharmaceuticals (IONS) announced the FDA has granted Breakthrough Therapy designation to olezarsen as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia. The Breakthrough Therapy designation is based on results from the Phase 3 CORE and CORE2 studies of olezarsen. Ionis said the company is on track to submit a supplemental new drug application to the U.S. FDA by the end of the year.

"The Breakthrough Therapy designation reflects the groundbreaking nature of the pivotal CORE and CORE2 study results, in which olezarsen significantly lowered triglycerides below the risk threshold of acute pancreatitis in the vast majority of patients," said Sam Tsimikas, senior vice president, global cardiovascular development, Ionis.

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