Rare Daily Staff
Akcea Therapeutics said it is cutting its workforce by about 10 percent following the U.S. Food and Drug Administrations decision not to approve Waylivra, the company’s experimental therapy for familial chylomicronemia syndrome (FCS), an ultra-rare and potentially fatal disease.
In a filing with the U.S. Securities Commission, Akcea said the reorganization plan would impact U.S. team members primarily from the Waylivra field team and functions focused principally on Waylivra. Under the plan, the company expects to incur third quarter restructuring charges in the range of $2 million to $2.5 million.
FCS is a condition in which patients cannot metabolize triglyceride-rich lipid particles called chylomicrons due to a deficiency in the enzyme lipoprotein lipase. As a result, people with FCS have high levels of triglycerides in the blood, which leads to a range of symptoms including permanent organ damage and potentially fatal attacks of acute pancreatitis.
The companies did not disclose why the FDA chose not to approve the drug. There was expectation among investors that the agency would act in the company’s favor after an advisory committee voted 12 to 8 to recommend its approval despite some concerns about safety among some of the committee members.
The company previously said that it is working with the FDA to determine the path forward for Waylivra. Waylivra is also under regulatory review in the European Union and Canada for the treatment of people with FCS.
September 7, 2018