Posted by Michael Wonder on 04 Mar 2019
Akcea and Ionis receive positive EU CHMP opinion for Waylivra (volanesorsen)
1 March 2019 - First and only therapy approved for FCS, a serious and rare disease with no approved treatment options.
Akcea Therapeutics, announced today that the CHMP of the EMA has adopted a positive opinion recommending conditional marketing authorisation for Waylivra as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome who are at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.
