Rhythm Pharmaceuticals Expands IMCIVREE Authorization In UK For Acquired Hypothalamic Obesity
(RTTNews) - Rhythm Pharmaceuticals, Inc. (RYTM), a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, announced that the UK's MHRA has expanded marketing authorization for IMCIVREE (setmelanotide) to treat obesity and control hunger in adults and children aged 4 years and older with acquired hypothalamic obesity.
The expanded authorization covers patients with acquired hypothalamic obesity caused by hypothalamic injury or impairment, providing an approved treatment option for a condition previously lacking approved therapies in the UK.
The approval was supported by results from the Phase 2 and Phase 3 TRANSCEND trial, which enrolled 120 patients and achieved a statistically significant 19.8% placebo-adjusted reduction in BMI at 52 weeks.
Patients receiving setmelanotide achieved a 16.5% reduction in BMI, compared with a 3.3% increase with placebo. Adult patients achieved a 19.2% placebo-adjusted BMI reduction, while pediatric patients achieved a 20.2% reduction.
Setmelanotide treatment was also associated with reductions in hunger and was generally well tolerated in the TRANSCEND study.
The most common treatment-emergent adverse events included nausea, vomiting, diarrhea, injection-site reactions, skin hyperpigmentation and headache.
The TRANSCEND results were recently published in The New England Journal of Medicine, with an accompanying editorial highlighting the potential importance of targeted MC4R pathway therapy for acquired hypothalamic obesity.
The MHRA also granted orphan drug designation for IMCIVREE in acquired hypothalamic obesity, further supporting its development and availability for this rare neuroendocrine condition.
Rhythm plans to work with the UK National Health Service (NHS) to finalize coverage guidance for IMCIVREE in acquired hypothalamic obesity.
The expanded authorization marks an important milestone for Rhythm as it broadens the use of IMCIVREE across rare forms of obesity and advances its strategy of targeting the MC4R pathway to address severe hunger and obesity associated with underlying neuroendocrine disorders.
RYMT is currently trading at $115, down 0.42%.
