Human medicines European public assessment report (EPAR): Imcivree, setmelanotide, Date of authorisation: 16/07/2021, Revision: 8, Status: Authorised
In 2 main studies, Imcivree was shown to be effective at reducing body weight by at least 10% in people with POMC and LEPR deficiency.
The first study was carried out in 10 patients with obesity due to POMC 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 study that included 28 patients aged 12 years or older with BBS, around 36% of the patients achieved at least a 10% reduction in body weight after one year of treatment.
Imcivree was not compared to another medicine in these studies.
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