On Thursday, May 10, 2018, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) discussed the safety and efficacy of volanesorsen (VLN) solution for subcutaneous injection, submitted by Akcea Therapeutics, Inc. (Akcea) for the treatment of patients with familial chylomicronemia syndrome (FCS). VLN was discovered by Ionis Pharmaceuticals, Inc. (Ionis), co-developed by Ionis and Akcea, and, if approved, will be commercialized by Akcea.

The FDA’s PDUFA goal data to decide on approval is August 30, 2018.

A majority of the Committee, 12 of 20 members, voted that, based on the information included in the briefing materials and presented at the meeting, Akcea has provided sufficient efficacy and safety data to support approval of volanesorsen