Research & Development
US Metabolism and Endocrinology Products Advisory Committee votes for approval of Akcea Therapeutics' Waylivratm
14 May 2018 -

The Metabolism and Endocrinology Products Advisory Committee, a division of The US Food and Drug Administration (FDA), has voted 12-8 to support approval of United States-based Akcea Therapeutics' Waylivratm (volanesorsen) intended for the treatment of familial chylomicronemia syndrome (FCS), it was reported on Friday.

The committee's non-binding recommendation will be considered by the US Food and Drug Administration (FDA) in its review of the company's New Drug Application for WAYLIVRA. The Prescription Drug User Fee Act (PDUFA) date for completion of the WAYLIVRA review is 30 August 2018.

The Advisory Committee reviewed data from two Phase three clinical trials, APPROACH and COMPASS, and the ongoing APPROACH Open Label study for WAYLIVRA. Results from the phase 3 APPROACH trial, the largest study ever conducted in patients with FCS, show that patients with the condition treated with WAYLIVRA achieved a statistically significant mean reduction in harmful triglycerides of 77% from baseline and decreased risk of pancreatitis.

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