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On 21 July 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Imcivree1. The marketing authorisation holder for this medicinal product is Rhythm Pharmaceuticals Netherlands B.V.

The CHMP adopted a new indication to include treatment of obesity and hunger control in patients with Bardet‑Biedl syndrome (BBS).

For information, the full indications for Imcivree will therefore be as follows2:

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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

1 This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained
2 New text in bold

Key facts

Agency product number
International non-proprietary name (INN) or common name
  • setmelanotide
Active substance
  • Setmelanotide
Therapeutic area
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.


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.

Date opinion adopted
Company name
Rhythm Pharmaceuticals Netherlands B.V.
Application type

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