Ionis Pharmaceuticals, Inc. took another step forward on its path to bringing its first wholly-owned drug to market without a partner on 26 September when it reported positive topline results from the Phase III BALANCE clinical trial of olezarsen in the treatment of familial chylomicronemia syndrome (FCS). The company plans to file for US and EU approvals during the first half of 2024 and, if granted priority review, expects US Food and Drug Administration approval before the end of next year and a launch soon after.
Ionis Closer To First Wholly-Owned Drug Launch With Olezarsen Phase III Success
Drug Targets apoC-III To Lower Triglycerides
Ionis will seek US and EU approvals to treat familial chylomicronemia syndrome in the first half of 2024. Phase III data in the larger severe hypertriglyceridemia indication are due in late 2024 or early 2025.
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