June 16, 2022

The U.S. FDA has approved Imcivree® (setmelanotide – Rhythm Pharmaceuticals) to treat of obesity and control hunger in patients who are at least six years old and have Bardet-Biedl 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 POMC, PCSK1, or LEPR deficiency confirmed by genetic testing in which variants in POMC, PCSK1, or LEPR genes are interpreted as pathogenic, likely pathogenic, or of uncertain significance.
  • Bardet-Biedl syndrome is a rare, complex genetic disorder that can cause hyperphagia, an abnormally strong feeling of hunger or desire to eat. Hyperphagia 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. Imcivree is administered by subcutaneous injection.
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