In the wake of the FDA’s rejection of Waylivra for the treatment of familial chylomicronaemia syndrome (FCS), Akcea Therapeutics disclosed that it plans to cut 10 percent of its workforce.
The company received a complete response letter from the FDA last week, and the accompanying press release offered only that the letter was in regards to Akcea’s marketing application for Waylivra. Previously, despite concerns raised over platelet declines that led to five patients discontinue treatment during the study, Waylivra received a favorable outcome, with the advisory committee voting 12-8.
According the Akcea, those most impacted by the job cuts will be the Waylivra U.S. field team, as well as some other positions focused on the rejected drug.
Currently, Waylivra remains under review in both Europe and Canada.