Rhythm Pharmaceuticals Receives FDA Approval for Drug to Control Obesity in People with Bardet-Biedl Syndrome (BBS)
Eye On the Cure Research News
The newly approved drug reduces the pathologic hunger associated with BBS
The US Food & Drug Administration has approved the use of IMICREE® (setmelanotide) for the treatment of chronic obesity associated with Bardet-Biedl syndrome (BBS). Developed by Rhythm Pharmaceuticals, IMICREE is available for BBS patients 6 years of age and older.
BBS is a genetic condition that can cause multiple symptoms including: retinitis pigmentosa; heart, kidney, and liver problems; extra fingers and toes; and weight management challenges due to insatiable hunger. People with BBS may not have all of the associated symptoms. Approximately 1,500-2,500 people in the US have BBS.
In the Phase 3 clinical trial for 31 patients with BBS, mean percent change in body mass index (BMI) was -7.9% at 52 weeks of treatment without requirements for diet and exercise.
IMCIVREE was initially approved by the FDA in November 2020 for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency.