Posted by Michael Wonder on 08 May 2019
Akcea and Ionis announce approval of Waylivra (volanesorsen) in the European Union
7 May 2019 - Akcea Therapeutics and Ionis Pharmaceuticals announced today that Waylivra has received conditional marketing authorisation from the European Commission as an adjunct to diet in adult patients with genetically confirmed FCS and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.
This authorisation follows the positive opinion recommending approval provided by the CHMP of the EMA.
As part of the conditional marketing authorisation, Akcea and Ionis will conduct a non-interventional post-authorisation safety study based on a registry.
