FDA approves Imcivree for obesity due to POMC, PCSK1 or leptin receptor (LEPR) deficiencies confirmed by genetic testing.- Rhythm Pharmaceuticals

The FDA has authorised Imcivree (setmelanotide), from Rhythm Pharmaceuticals, for chronic weight management in adults and paediatric patients six years of age and older with obesity due to POMC, PCSK1 or leptin receptor (LEPR) deficiencies confirmed by genetic testing. The company noted that the approval makes the drug the first-ever therapy cleared in the US for these genetic diseases of obesity.The FDA filing was approved based on a review of Phase III trial data, recently published in The Lancet Diabetes & Endocrinology, demonstrating that 80% of patients with obesity due to POMC or PCSK1 deficiency, and 45.5% of those with LEPR deficiency obesity, achieved at least 10% weight loss after one year of treatment with Imcivree. Further, the mean percent change in "most hunger" score in participants aged 12 years and older was -27.1% in POMC deficiency obesity and -43.7% in LEPR deficiency obesity. Rhythm indicated that Imcivree was generally well tolerated in clinical studies, with the most common side effects being injection-site reactions, skin hyperpigmentation and nausea. The company noted that warnings and precautions associated with the drug include disturbance in sexual arousal, depression and suicidal ideation.