Rhythm Pharmaceuticals, Inc. announced that the Canadian Agency for Drugs and Technologies in Health (CADTH) has recommended that IMCIVREE® (setmelanotide) be reimbursed by CADTH-participating public drug plans, with conditions, for weight management in adult and pediatric patients six years of age and older with obesity due to Bardet-Biedl syndrome (BBS). CADTH?s recommendation is based on results from Rhythm?s Phase 3 trial that demonstrated treatment with setmelanotide resulted in meaningful clinical benefit in patients 6 years of age and older with obesity due to BBS. Data showed that treatment with setmelanotide for 52 weeks resulted in a clinically meaningful reduction in weight-related parameters, such as total body weight and body mass index (BMI), and the results were supported by the exploratory comparative 14-week placebo-controlled outcomes.

Consistent with prior clinical experience, setmelanotide was generally well tolerated. Treatment-emergent adverse events (TEAEs) included mild injection site reactions and nausea. BBS is a rare genetic disease with an estimated prevalence of 1 in 100,000 to 160,000 in the populations of North America and Europe with an estimated 300-400 people living with the disease in Canada.

People living with BBS may experience insatiable hunger, also known as hyperphagia, and severe obesity beginning early in life. BBS may also be associated with cognitive impairment, polydactyly, renal dysfunction, hypogonadism, and visual impairment. IMCIVREE® (setmelanotide) is the first and only therapy approved in Canada for weight management in adult and pediatric patients 6 years of age and older with obesity due to BBS.

IMCIVREE® (setmelanotide) was given a Priority Review by Health Canada.