Winfuran

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Questions and answers

On 17 January 2014, Toray International U.K. Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Winfuran, intended for the treatment of severe uraemic pruritus (a form of itching) in patients with end-stage kidney disease on dialysis.

What is Winfuran?

Winfuran is a medicine that contains the active substance nalfurafine. It was to be available as a concentrate for solution for infusion into a vein.

What was Winfuran expected to be used for?

Winfuran was expected to be used for the treatment of patients with severe uraemic pruritus. Uraemic pruritus is a persisting form of itching that occurs in some patients whose kidneys are not functioning properly. Winfuran was to be used in patients with end-stage renal disease (when the kidneys have stopped working completely) and who are on dialysis (a technique for removing waste products from the blood).

Winfuran was designated an ‘orphan medicine’ (a medicine to be used in rare diseases) on 11 September 2002 for uraemic pruritus. 

How is Winfuran expected to work?

Although the exact cause of uraemic pruritus is not known it is thought that the itching is linked to an excessive activity of certain receptors called mu-opioid receptors in the brain and skin. Winfuran activates different opioid receptors, called kappa receptors, which block the activity of the mu-opioid receptors and therefore relieve the itching in patients with uraemic pruritus.

What did the company present to support its application?

The effects of Winfuran were first tested in experimental models before being studied in humans.

The effects of Winfuran were compared with placebo (a dummy treatment) in one main study involving 339 patients with uraemic pruritus who were on regular dialysis. The main measure of effectiveness was the change in symptoms such as itching intensity and sleep disturbance after 4 weeks of treatment based on a standard scoring system.

How far into the evaluation was the application when it was withdrawn?

The evaluation had finished and the CHMP had given a negative opinion.

What was the recommendation of the CHMP at that time?

Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Winfuran for the treatment of severe uraemic pruritus.

The CHMP’s main concern was that the benefits of Winfuran in the treatment of uraemic pruritus had not been sufficiently shown. The main study failed to show that Winfuran was more effective than placebo at relieving itching. Although an additional analysis showed a modest benefit in a subpopulation of patients with a severe form of uraemic pruritus, the CHMP considered that the clinical relevance had not been shown. Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Winfuran did not outweigh its risks and it concluded that the medicine could not have been approved on the basis of the data presented by the company.

What were the reasons given by the company for withdrawing the application?

In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided do not allow the Committee to conclude on a positive benefit-risk balance.

What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?

The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes for Winfuran.

Name Language First published Last updated
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) BG = bălgarski 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) ES = español 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) CS = čeština 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) DA = dansk 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) DE = Deutsch 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) ET = eesti keel 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) EL = elliniká 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) EN = English 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) FR = français 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) IT = italiano 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) LV = latviešu valoda 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) LT = lietuvių kalba 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) HU = magyar 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) MT = Malti 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) NL = Nederlands 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) PL = polski 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) PT = português 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) RO = română 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) SK = slovenčina 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) SL = slovenščina 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) FI = suomi 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) SV = svenska 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) HR = Hrvatski 2014-01-24  

News

Key facts

Product details for Winfuran
NameWinfuran
Product numberEMEA/H/C/002683
Date of issue of marketing authorisation valid throughout the European Union (if applicable)
International non-proprietary name or common name

nalfurafine

Active substancenalfurafine
Date of withdrawal17/01/2014
Company making the application

Toray International U.K. Limited

Withdrawal typeInitial authorisation

All documents

Name Language First published Last updated
Withdrawal assessment report for Winfuran (English only) 2014-03-11  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) BG = bălgarski 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) ES = español 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) CS = čeština 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) DA = dansk 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) DE = Deutsch 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) ET = eesti keel 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) EL = elliniká 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) EN = English 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) FR = français 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) IT = italiano 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) LV = latviešu valoda 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) LT = lietuvių kalba 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) HU = magyar 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) MT = Malti 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) NL = Nederlands 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) PL = polski 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) PT = português 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) RO = română 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) SK = slovenčina 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) SL = slovenščina 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) FI = suomi 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) SV = svenska 2014-01-24  
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) HR = Hrvatski 2014-01-24  
Withdrawal letter: Winfuran (English only) 2013-01-24  

Related information

More information on Winfuran

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').