Waylivra
What Waylivra is used for
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.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
- Conditional approval: approved on less complete data because the need is high; more data must follow.
Key facts
- Brand
- Waylivra
- Active substance
- volanesorsen
- Disease area
- Hyperlipoproteinemia Type I
- Medicine group
- Other lipid modifying agents
- ATC code
- C10AX18
- Marketing authorisation holder
- Akcea Therapeutics Ireland Limited
- Authorised in the EU since
- 2019
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Waylivra used for?
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.
What is the active substance in Waylivra?
Waylivra contains volanesorsen.
Who makes Waylivra?
The EU marketing authorisation holder is Akcea Therapeutics Ireland Limited.
Is Waylivra an orphan medicine?
Yes. Waylivra is designated an orphan medicine in the EU, for a rare disease (Hyperlipoproteinemia Type I).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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