This website is not intended or suitable for UK healthcare professionals.
UK HCPs should contact EU_medinfo@rhythmtx.com if they require information. A UK specific website will be available soon.
precision medicine
Target the root, restore the balance
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
IMCIVREE SmPC/Prescribing information
IMCIVREE – the first and only precision medicine to target MC4R pathway impairment, a root cause of hyperphagia and obesity.1
IMCIVREE (setmelanotide) 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.1
IMCIVREE is designed to re-establish melanocortin-4 receptor (MC4R) pathway activity in the hypothalamus to reduce hunger and promote weight loss through decreased caloric intake and increased energy expenditure.1
Previously, there was an unmet medical need for patients with BBS or POMC, PCSK1 and LEPR deficiency because available treatment options for general obesity do not address the underlying genetic cause of obesity.2-8
IMCIVREE was the first medicine to be studied in multiple phase 3 clinical trials dedicated to hyperphagia (pathological, insatiable hunger) and obesity in patients with BBS or POMC, PCSK1 and LEPR deficiency.9,10
IMCIVREE delivered significant and clinically meaningful weight loss over 1 year.9,10

IMCIVREE is generally well-tolerated.1
Across all patients, the most reported treatment-emergent adverse events were hyperpigmentation disorders, injection site reactions, nausea and headache.1
Follow the below links to explore how IMCIVREE targets a root cause of hyperphagia and early-onset, severe obesity caused by BBS or POMC, PCSK1 and LEPR deficiency.
For more scientific information about the MC4R pathway
Click here

All adverse events should be reported. For medical information, to report an adverse event or product complaint please contact eu_medinfo@rhythmtx.com

References:

  1. IMCIVREE Summary of Product Characteristics. March 2023.
  2. Styne DM, et al. J Clin Endocrinol Metab. 2017;102(3):709–757.
  3. Heymsfield SB, et al. NAM Perspectives. DOI: 10.31478/201809B.
  4. Belviq. Prescribing information. Arena Pharmaceuticals, Inc; 2017.
  5. Contrave. Prescribing information. Nalpropion Pharmaceuticals, Inc; 2018.
  6. Qsymia. Prescribing information. Vivus, Inc; 2018.
  7. Saxenda. Prescribing information. Novo Nordisk; 2018.
  8. Xenical. Prescribing information. H2-Pharma, LLC; 2017.
  9. Clément K, et al. Lancet Diabetes Endocrinol 2020;8(12):960–970.
  10. Haqq AM, et al. Lancet Diabetes Endocrinol. 2022;10(12):859–868.
  11. Forsythe E, Beales PL. Eur J Hum Genet 2013;21(1):8–13.
  12. Huvenne H, et al. Obes Facts. 2016;9(3):158–173.