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April 14, 2022 – The U.S. FDA has approved Imcivree® (setmelanotide) for treatment of obesity and control of hunger in patients who are at least six years old and have Bardet-Biedl syndrome or Alström syndrome.
- Imcivree first received FDA approval in 2020. It is also indicated for chronic weight management in patients at least six years old who have obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance.
- Bardet-Biedl syndrome and Alström syndrome are rare, complex genetic disorders that can have a wide range of symptoms. These symptoms can include hyperphagia, an abnormally strong feeling of hunger or desire to eat, which can lead to obesity and may be present as early as the patient’s first year of life.
- Recommended dosing under the new indication is based on the patient’s age, renal health, and clinical response to treatment. Daily dosing can range from 0.25mg to 3mg administered via subcutaneous injection. Imcivree can be self-administered or administered by a caregiver once the individual has been trained in proper technique.