CHMP recommends Imcrivee for the treatment of obesity and control of hunger in adult and pediatric patients 6 years of age and older with genetically confirmed Bardet-Biedl syndrome
Rhythm Pharmaceuticals, Inc. a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases, announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending to expand the current marketing authorization for Imcrivee (setmelanotide) to include the treatment of obesity and control of hunger in adult and pediatric patients 6 years of age and older with genetically confirmed Bardet-Biedl syndrome (BBS)
Philip Beales, M.D., University College London, Institute of Child Health, said, “Patients living with BBS are looking for a transformational treatment that can significantly reduce hunger and body weight. If approved, setmelanotide could change the treatment paradigm for these patients and their families, providing them an option that not only has the potential to address the physical aspects of the disease, but also its negative effects on overall health, well-being and quality of life.”