Imcivree

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setmelanotide

Authorised
This medicine is authorised for use in the European Union.

Overview

Imcivree is a medicine used to treat obesity and help control hunger caused by certain genetic conditions that affect how the brain controls feelings of hunger. It is used in adults and children aged 6 years and older with Bardet Biedl syndrome (BBS), and in those who have pro-opiomelanocortin (POMC) deficiency or leptin receptor (LEPR) deficiency resulting from changes (mutations) in both copies of the genes responsible for making POMC or LEPR.

Bardet Biedl syndrome, pro-opiomelanocortin deficiency and leptin receptor deficiency are rare, and Imcivree was designated an ‘orphan medicine’ (a medicine used in rare diseases). Further information on the orphan designations can be found on the European Medicines Agency’s website (pro-opiomelanocortin deficiency: 14 July 2016; leptin receptor deficiency: 19 November 2018; Bardet Biedl syndrome: 21 August 2019).

Imcivree contains the active substance setmelanotide.

This EPAR was last updated on 22/11/2022

Authorisation details

Product details
Name
Imcivree
Agency product number
EMEA/H/C/005089
Active substance
Setmelanotide
International non-proprietary name (INN) or common name
setmelanotide
Therapeutic area (MeSH)
Obesity
Anatomical therapeutic chemical (ATC) code
A08AA
Additional monitoringAdditional 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.

OrphanOrphan

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.

Publication details
Marketing-authorisation holder
Rhythm Pharmaceuticals Netherlands B.V.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
16/07/2021
Contact address

Radarweg 29
1043NX Amsterdam
Netherlands

Product information

31/10/2022 Imcivree - EMEA/H/C/005089 - IB/0012

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antiobesity preparations, excl. diet products

Therapeutic indication

Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet Biedl syndrome (BBS), loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above.

Assessment history

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