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Ionis Pharmaceuticals Says FDA Accepts Metabolic Disorder Drug Candidate for Priority Review
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Ionis Pharmaceuticals Says FDA Accepts Metabolic Disorder Drug Candidate for Priority Review
Jun 25, 2024 5:10 AM

07:55 AM EDT, 06/25/2024 (MT Newswires) -- Ionis Pharmaceuticals ( IONS ) said Tuesday that the US Food and Drug Administration has accepted for priority review the new drug application for its experimental drug, olezarsen, which is intended to treat adults with familial chylomicronemia syndrome, a genetic metabolic disorder.

The FDA has set an action date of Dec. 19 and is not planning an advisory meeting of olezarsen.

The company said it is also evaluating olezarsen for treating severe hypertriglyceridemia in three phase 3 trials, the results of which are expected in H2 2025.

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