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Waylivra - About FCS

Waylivra is the only medicine licensed* and recommended by NICE for the treatment of FCS1,2*

 

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.1

Treatment should be initiated by and remain under the supervision of a physician experienced in the treatment of patients with FCS

* Waylivra is licensed under a conditional marketing authorisation.

 

FCS is a debilitating disease with a high risk of pancreatitis due to high TG levels.3,6 

Observational data suggest that the incidence of acute pancreatitis increases +3% for every increment of 100 mg/dL in TG levels >1000 mg/dL; therefore, a decrease in TG levels to any extent below this threshold may result in a decrease in the risk of acute pancreatitis.10

Waylivra indication

 

FCS: familial chylomicronemia syndrome, NICE: National Institute for Health and Care Excellence, OLE: open-label extension, TG: triglycerides

References

  1. Waylivra Summary of Product Characteristics. 
  2. ©NICE 2020 Volanesorsen for treating familial chylomicronaemia syndrome. Available from www.nice.org.uk/guidance/hst13. All rights reserved. Subject to notice of rights. (Accessed March 2025).
  3. Gaudet D et al. N Engl J Med 2014;371(23):2200–6. 
  4. Feingold KR. In: Feingold KR et al. Editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK305896/ (Accessed March 2025).
  5. Stroes E et al. Atheroscler Suppl 2017;23:1–7.
  6. Davidson M et al. J Clin Lipidol 2018;12(4):898–907.e2.
  7. Davidson M et al. Expert Rev Cardiovasc Ther 2017;15(5):415–23.
  8. Brunzell JD, Bierman EL. Med Clin North Am 1982;66(2):455–68.
  9. Moulin P et al. Atherosclerosis 2018;275:265–72.
  10. Witzum JL et al. N Engl J Med 2019;381(6):531–42.
  11. EMA. Waylivra assessment report. Available from: https://www.ema.europa.eu/en/documents/assessment-report/waylivra-epar-public-assessment-report_en.pdf (Accessed March 2025).

 

 

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.  Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Swedish Orphan Biovitrum Ltd at [email protected] or Telephone +44 (0) 800 111 4754

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