This medicine is authorised for use in the European Union.


Waylivra is a medicine used to treat familial chylomicronaemia syndrome (FCS), a genetic condition that gives rise to high levels of fats called triglycerides in the blood. Excess fat builds up in various parts of the body and leads to symptoms including abdominal pain (belly ache), deposits of fat under the skin and pancreatitis (inflammation of the pancreas).

Waylivra, along with a low fat diet, is used to reduce triglyceride blood levels in patients with FCS that has been confirmed by genetic testing. It is only given to patients in whom other medicines to reduce triglycerides have not worked and who are at high risk of developing pancreatitis.    

FCS is rare, and Waylivra was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 February 2014. 

Waylivra contains the active substance volanesorsen.

This EPAR was last updated on 08/11/2022

Authorisation details

Product details
Agency product number
Active substance
Volanesorsen sodium
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Hyperlipoproteinemia Type I
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Akcea Therapeutics Ireland Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Akcea Therapeutics Ireland Limited
St. James House
72 Adelaide Road, Dublin 2
D02 Y017

Product information

08/11/2022 Waylivra - EMEA/H/C/004538 - IAIN/0023

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other lipid modifying agents

Therapeutic indication

Waylivra is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.

Assessment history

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