European Commission approves Waylivra to treat patients with familial chylomicronemia syndrome at high risk for pancreatitis

Akcea Therapeutics, Inc.,an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. announced that Waylivra has received conditional marketing authorization from the European Commission (EC) as an adjunct to diet in adult patients with genetically confirmed FCS (familial chylomicronemia syndrome) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate

As part of the conditional marketing authorization, Akcea and Ionis will conduct a non-interventional post-authorization safety study (PASS) based on a Registry. Waylivra is the only treatment available for patients with FCS and Akcea plans to launch it in Germany this year followed by additional European countries in 2020.