Rhythm Pharmaceuticals, Inc discovers first-of-its-kind setmelanotide for the treatment of obesity.
Setmelanotide is not indicated for treating patients with suspected obesity due to POMC, PCSK1 or LEPR deficiency with POMC, PCSK1 or LEPR variants classified as benign or likely benign. It is also not indicated for obesity related with other genetic syndromes and general (polygenic) obesity.
Some of the side effects of caused with the treatment of Setmelanotide include skin pigmentation, depression, prolonged penile erection etc. For every six months monitoring of heart rate and blood pressure should be done as an essential standard clinical practice for patients treated with setmelanotide.
U.S. Food and Drug Administration (FDA) grants Setmelanotide, the breakthrough designation for the treatment of hypothalamic obesity.
Hypothalamic obesity is a rare cause of extreme obesity that damages the hypothalamic region of the brain including MC4R pathway. It also controls physiological functions such as hunger and weight regulation.
Patients with hypothalamic experience quick weight gain, reduction in energy expenditure and increase in hunger during first six to 12 months following tumor resection, and all these factors ultimately leading to severe obesity.
In U.S, currently there are approximately 5,000-10,000 patients suffering with hypothalamic obesity, giving rise to 500 new cases every year.
