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  1. Home
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  3. Imcivree - withdrawal of application for variation to marketing authorisation

Imcivree - withdrawal of application for variation to marketing authorisation

Application withdrawn

The application for a change to this medicine's authorisation has been withdrawn.

setmelanotide
Post-authorisationHuman

Page contents

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

Overview

Rhythm Pharmaceuticals Netherlands B.V. withdrew its application for the use of Imcivree to treat obesity and control hunger associated with genetically confirmed Alström syndrome.

The company withdrew the application on 22 April 2022.

Imcivree is a medicine used to treat obesity and help control hunger in people with certain genetic conditions that affect how the brain controls feelings of hunger. It is used in adults and children aged 6 years and older who have conditions known as pro-opiomelanocortin (POMC) deficiency or leptin receptor (LEPR) deficiency.

The medicine has been authorised in the EU since July 2021.

Imcivree contains the active substance setmelanotide.

Further information on Imcivree’s current uses can be found on the Agency’s website: ema.europa.eu/medicines/human/EPAR/imcivree

The company applied to extend the use of Imcivree to treat obesity and control hunger associated with genetically confirmed Alström syndrome. Alström syndrome is a rare genetic disease that causes a variety of problems in several organs across the body.

Imcivree was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 9 January 2020 for treatment in people with Alström syndrome.

Further information on the orphan designation can be found on the Agency’s website: ema.europa.eu/medicines/human/orphan-designations/.eu-3-19-2245.

The active substance in Imcivree, setmelanotide, attaches to a receptor in the brain called melanocortin receptor 4, which promotes a feeling of fullness after eating. By attaching to this receptor, Imcivree is expected to reduce excessive food intake and obesity.

In patients with Alström syndrome, the signals that control appetite and how the body produces energy are disrupted. In these patients, Imcivree is expected to work in the same way as it does in its existing indications.

The company presented the results of a study which included 6 patients with Alström syndrome. The study compared Imcivree with placebo (a dummy treatment) and looked at the proportion of patients who achieved a clinically meaningful reduction in body weight.

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, at the time of the withdrawal, the Agency had some concerns and its provisional opinion was that Imcivree could not have been authorised for treating obesity and controlling hunger in people with genetically confirmed Alström syndrome.

The Agency’s opinion was that the company had not provided enough information to support the application for a change to the marketing authorisation of Imcivree. The small number of patients with Alström syndrome included in the trial and the lack of adequate data did not allow the Agency to establish the benefits of the medicine in the proposed indication.

In its letter notifying the Agency of the withdrawal of application, the company stated that its withdrawal was based on the Agency’s consideration that the data submitted were insufficient to conclude on a positive benefit-risk balance in the proposed indication.

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

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 Imcivree in its authorised uses.

Questions and answers on the withdrawal of application to change the marketing authorisation for Imcivree (setmelanotide)

Reference Number: EMA/687359/2022

English (EN) (97.64 KB - PDF)

First published: 22/07/2022Last updated: 28/09/2022
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Other languages (22)

български (BG) (110.11 KB - PDF)

First published: 22/07/2022Last updated: 28/09/2022
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español (ES) (96.02 KB - PDF)

First published: 22/07/2022Last updated: 28/09/2022
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čeština (CS) (100.97 KB - PDF)

First published: 22/07/2022Last updated: 28/09/2022
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dansk (DA) (97.22 KB - PDF)

First published: 22/07/2022Last updated: 28/09/2022
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Deutsch (DE) (100.85 KB - PDF)

First published: 22/07/2022Last updated: 28/09/2022
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eesti keel (ET) (93.85 KB - PDF)

First published: 22/07/2022Last updated: 28/09/2022
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ελληνικά (EL) (109.01 KB - PDF)

First published: 22/07/2022Last updated: 28/09/2022
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français (FR) (100 KB - PDF)

First published: 22/07/2022Last updated: 28/09/2022
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hrvatski (HR) (97.7 KB - PDF)

First published: 22/07/2022Last updated: 28/09/2022
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italiano (IT) (96.8 KB - PDF)

First published: 22/07/2022Last updated: 28/09/2022
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First published: 22/07/2022Last updated: 28/09/2022
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First published: 22/07/2022Last updated: 28/09/2022
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Malti (MT) (109.55 KB - PDF)

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Nederlands (NL) (98.79 KB - PDF)

First published: 22/07/2022Last updated: 28/09/2022
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polski (PL) (100.29 KB - PDF)

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română (RO) (99.07 KB - PDF)

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slovenčina (SK) (100.82 KB - PDF)

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Key facts

Name of medicine
Imcivree
EMA product number
EMEA/H/C/005089
Active substance
Setmelanotide
International non-proprietary name (INN) or common name
setmelanotide
Therapeutic area (MeSH)
Obesity
Anatomical therapeutical chemical (ATC) code
A08AA

Additional 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.

Orphan

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.

PRIME: priority medicine

This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines.

Marketing authorisation holder
Rhythm Pharmaceuticals Netherlands B.V.
Date of issue of marketing authorisation valid throughout the European Union
16/07/2021
Date of withdrawal
22/04/2022

Documents

Withdrawal assessment report for Imcivree

AdoptedReference Number: EMA/677095/2022

English (EN) (5.1 MB - PDF)

First published: 28/09/2022
View

Withdrawal letter: Imcivree

English (EN) (112.23 KB - PDF)

First published: 21/07/2022
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 Imcivree

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024
28/06/2024
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2022
22/07/2022
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2022
22/07/2022
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 May 2021
21/05/2021
New treatment for obesity caused by rare genetic disorders
21/05/2021

More information on Imcivree

  • Imcivree
This page was last updated on 28/09/2022

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