Volanesorsen backed by majority in FDA panel vote

Safety concerns could not stop the majority of a US Food and Drug Administration (FDA) advisory committee voting in favor of approving volanesorsen for familial chylomicronemia syndrome (FCS), a rare lipid disorder with no therapeutic options.

Volanesorsen is being developed under the brand name Waylivra by Akcea Therapeutics (Nasdaq: AKCA), an affiliate of the US biotech company Ionis Pharmaceuticals (Nasdaq: IONS).

Safety issues were discussed by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, with platelet-related adverse events that have occurred in trial patients a particular concern.