Waylivra

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volanesorsen

Authorised
This medicine is authorised for use in the European Union.

Overview

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. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3141249.

Waylivra contains the active substance volanesorsen.

This EPAR was last updated on 20/08/2019

Authorisation details

Product details
Name
Waylivra
Agency product number
EMEA/H/C/004538
Active substance
Volanesorsen sodium
International non-proprietary name (INN) or common name
volanesorsen
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.

OrphanOrphan

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
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
03/05/2019
Contact address

Regus House, Harcourt Centre,
Harcourt Road
Dublin 2
Ireland

Product information

18/07/2019 Waylivra - EMEA/H/C/004538 - IB/0001

Contents

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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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