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  1. Home
  2. Medicines
  3. Ilaris - withdrawal of application for variation to marketing authorisation

Ilaris - withdrawal of application for variation to marketing authorisation

Application withdrawn

The application for a change to this medicine's authorisation has been withdrawn.

canakinumab
Post-authorisationHuman

Page contents

  • Overview
  • Key facts
  • Documents
  • Related information on withdrawals
  • News on Ilaris
  • More information on Ilaris

Overview

Novartis withdrew its application for the use of Ilaris in the treatment of Schnitzler syndrome.

The company withdrew the application on 26 October 2022.

Ilaris is a medicine used to treat several inflammatory conditions, including Still’s disease, gouty arthritis and several types of periodic fever syndromes. It has been authorised in the EU since October 2009.

It contains the active substance canakinumab and is given as an injection under the skin.

The company applied to extend the use of Ilaris to treat Schnitzler syndrome, a rare long-term inflammatory disease causing urticaria (hives), recurrent fever, bone and joint pain, and swollen lymph nodes.

In patients with Schnitzler syndrome, Ilaris is expected to work in the same way as it does in its existing indications. The active substance in Ilaris, canakinumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a messenger molecule or ‘cytokine’ in the body called interleukin?1 beta. This messenger is involved in causing inflammation and is found in high levels in patients with inflammatory conditions. By attaching to interleukin?1 beta, canakinumab blocks its activity, helping to reduce inflammation thereby relieving the symptoms of the disease.

The company presented the results of a main study in 20 patients with Schnitzler syndrome comparing the effects of Ilaris with those of placebo. The study looked at the proportion of patients who had no or minimal disease activity after 7 days of treatment, based on the assessment of 5 key symptoms. In addition the company presented supportive evidence from additional smaller studies described in the literature.

The application was withdrawn after the European Medicines Agency had evaluated the information from the company and had prepared questions for the company. After the Agency had assessed the company’s responses to the questions, there were still some unresolved issues.

Based on the review of the information and the company’s response to the Agency’s questions, at the time of the withdrawal, the Agency had some concerns and its provisional opinion was that Ilaris could not have been authorised for the use in Schnitzler syndrome.

The Agency’s main concerns were about the way the main study had been conducted, which raised questions about the accuracy and validity of the data. In particular, the Agency considered the quality of documentation insufficient to carry out an adequate assessment and found errors in the randomisation process affecting the accuracy and reliability of results.

Therefore, at the time of the withdrawal, the Agency’s opinion was that it was not possible to come to reliable conclusions on how well the medicine works in the treatment of Schnitzler syndrome and the Agency therefore considered that the benefits of Ilaris does not outweigh its risks for this use.

In its Withdrawal letter: Ilaris notifying the Agency of the withdrawal of application, the company stated that the withdrawal is based on the fact that the available data were not considered sufficient to conclude on a benefit-risk balance for the proposed indication.

The company informed the Agency that there are no consequences for patients in clinical trials using Ilaris.

If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.

There are no consequences on the use of Ilaris in its authorised uses.

Questions and answers on the withdrawal of application to change the marketing authorisation for Ilaris (canakinumab) (II-0075)

Reference Number: EMEA/H/C/001109/II/75

English (EN) (145.56 KB - PDF)

First published: 11/11/2022Last updated: 23/02/2023
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български (BG) (140.46 KB - PDF)

First published: 11/11/2022Last updated: 23/02/2023
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español (ES) (88.54 KB - PDF)

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čeština (CS) (135.2 KB - PDF)

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dansk (DA) (88.95 KB - PDF)

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Deutsch (DE) (120.77 KB - PDF)

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eesti keel (ET) (88.07 KB - PDF)

First published: 11/11/2022Last updated: 23/02/2023
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ελληνικά (EL) (102.05 KB - PDF)

First published: 11/11/2022Last updated: 23/02/2023
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français (FR) (90.65 KB - PDF)

First published: 11/11/2022Last updated: 23/02/2023
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hrvatski (HR) (134.9 KB - PDF)

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italiano (IT) (114.2 KB - PDF)

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magyar (HU) (136.7 KB - PDF)

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Nederlands (NL) (117.4 KB - PDF)

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polski (PL) (136.92 KB - PDF)

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português (PT) (115.61 KB - PDF)

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română (RO) (163.08 KB - PDF)

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slovenčina (SK) (136.8 KB - PDF)

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Suomi (FI) (114.09 KB - PDF)

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Key facts

Name of medicine
Ilaris
EMA product number
EMEA/H/C/001109
Active substance
Canakinumab
International non-proprietary name (INN) or common name
canakinumab
Therapeutic area (MeSH)
  • Cryopyrin-Associated Periodic Syndromes
  • Arthritis, Juvenile Rheumatoid
  • Arthritis, Gouty
Anatomical therapeutical chemical (ATC) code
L04AC08
Marketing authorisation holder
Novartis Europharm Limited
Date of issue of marketing authorisation valid throughout the European Union
23/10/2009
Date of withdrawal
26/10/2022

Documents

Withdrawal assessment report for Ilaris

AdoptedReference Number: EMA/881775/2022

English (EN) (1.92 MB - PDF)

First published: 23/02/2023
View

Withdrawal letter: Ilaris

English (EN) (9.34 KB - PDF)

First published: 11/11/2022
View

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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 90').

News on Ilaris

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022
11/11/2022
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2016
16/12/2016
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2016
24/06/2016
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2013
26/07/2013
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 January 2013
18/01/2013
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2012
14/12/2012

More information on Ilaris

  • Ilaris
This page was last updated on 23/02/2023

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