Imcivree
Authorised
This medicine is authorised for use in the European Union
setmelanotide
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Imcivree is a medicine used to treat obesity and help control hunger caused by certain conditions that affect how the brain controls feelings of hunger. It is used:
- in adults and children aged 4 years and older with acquired hypothalamic obesity (aHO), a condition that occurs when the hypothalamus (a part of the brain) does not work properly, either following an injury or because of an underlying disease;
- in adults and children aged 2 years and older who have pro-opiomelanocortin (POMC) deficiency, proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency, or leptin receptor (LEPR) deficiency; these genetic conditions result from changes (mutations) in both copies of the genes responsible for making POMC, PCSK1 or LEPR;
- in adults and children aged 2 years and older with a genetic condition called Bardet Biedl syndrome (BBS).
These conditions 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 (acquired hypothalamic obesity: 13 October 2023; pro-opiomelanocortin deficiency: 14 July 2016; leptin receptor deficiency: 19 November 2018; Bardet Biedl syndrome: 21 August 2019).
Imcivree contains the active substance setmelanotide.
Imcivree can only be obtained with a prescription. Treatment should be prescribed and supervised by a doctor with expertise in treating obesity caused by genetic conditions or problems affecting the hypothalamus.
Imcivree is given once a day as an injection under the skin of the abdomen (belly). After being trained, patients or carers can inject the medicine themselves.
For more information about using Imcivree, see the package leaflet or contact your doctor or pharmacist.
The balance between how much energy a person takes in and how much they burn is regulated by the hypothalamus. In people with acquired hypothalamic obesity, this balance is disrupted.
People with POMC or PCSK1 deficiency have low levels of the hormone melanocyte-stimulating hormone (MSH). When levels of MSH are low, it can cause a person to not feel full after eating.
In people with LEPR deficiency and BBS, the receptor (target) for the hormone leptin does not work properly so signals to the nerves that make the body feel full and control feelings of hunger cannot be sent.
People with these conditions feel hungry continuously and quickly gain weight.
The active substance in Imcivree, setmelanotide, attaches to and activates a receptor called melanocortin receptor 4, which is normally activated through leptin and MSH, promoting a feeling of fullness after eating. By attaching to this receptor directly, Imcivree is expected to reduce excessive food intake and obesity.
Imcivree was found to reduce the body mass index (BMI; a measure of the patient’s weight in relation to their height) of people with acquired hypothalamic obesity in a main study.
The study involved 120 adults, adolescents and children from 4 years of age with acquired hypothalamic obesity. After one year of treatment, people who received Imcivree had an average reduction of their BMI of approximately 16.5% compared with a BMI increase of approximately 3.3% for people who received placebo (a dummy treatment). In addition, about 83% of people treated with Imcivree had BMI decreases that are expected to provide meaningful health benefits compared with 21% of those who received placebo.
In 3 other main studies, Imcivree was shown to be effective at reducing body weight by at least 10% in people with POMC, LEPR deficiency and BBS. Imcivree was not compared to another medicine or placebo in these studies.
The first study was carried out in 10 patients with obesity due to POMC or PCSK1 deficiency resulting from mutations in both copies of the genes for either POMC or PCSK1. After one year of treatment, 8 out of 10 people achieved at least a 10% reduction in body weight.
In the second study carried out in 11 patients with obesity due to LEPR deficiency caused by mutations in both copies of the gene for LEPR, 5 people out of 11 achieved at least a 10% reduction in body weight after one year.
The studies also looked at the effects of Imcivree on the feeling of hunger as measured using a questionnaire: the percentage of patients who achieved at least a 25% reduction in hunger scores was 50% in the first study and 73% in the second study.
In a third study that included 28 patients aged 12 years or older with BBS, around 36% of patients achieved at least a 10% reduction in body weight after one year of treatment.
Another study involved 12 children aged 2 to 5 years with obesity due to BBS or POMC, PCSK1 or LEPR deficiency. The study looked at the effect of Imcivree on their BMI, using the BMI Z-score which also takes age into account. After one year of treatment, 10 children achieved a decrease in their BMI Z-score of at least 0.2, meaning that they had a treatment effect. In addition, after a year of treatment, BMI scores decreased by an average of 18%; there was a 26% decrease on average in children with POMC, PCSK1 or LEPR deficiency and a 10% decrease on average for patients with BBS.
Studies carried out with Imcivree are described in more detail in the medicine’s assessment reports.
For the full list of side effects and restrictions of Imcivree, see the package leaflet.
The most common side effects with Imcivree (which may affect more than 1 in 10 people) include hyperpigmentation (coloration of the skin), injection site reactions, nausea (feeling sick) and headache.
The number of people with BBS, POMC, PCSK1 or LEPR deficiency is extremely small, so the number of people included in the studies was very limited. However, the studies showed that Imcivree helps to reduce bodyweight and feelings of hunger in these patients, although the effect of the medicine seems less pronounced in people with BBS. In people with acquired hypothalamic obesity, treatment with Imcivree led to reductions in BMI that are expected to provide meaningful health benefits in most patients. Imcivree’s side effects are manageable.
The European Medicines Agency therefore decided that Imcivree’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imcivree have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Imcivree are continuously monitored. Suspected side effects reported with Imcivree are carefully evaluated and any necessary action taken to protect patients.
Imcivree received a marketing authorisation valid throughout the EU on 16 July 2021.
Product information
Latest procedure affecting product information:VR/0000288021
30/04/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Imcivree
- Active substance
- setmelanotide
- International non-proprietary name (INN) or common name
- setmelanotide
- Therapeutic area (MeSH)
- Obesity
- Anatomical therapeutic chemical (ATC) code
- A08AA
Pharmacotherapeutic group
Antiobesity preparations, excl. diet productsTherapeutic 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 2 years of age and above.
News on Imcivree
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