Rhythm Pharmaceuticals Completes Submission of Type II Variation Application to the European Medicines Agency for IMCIVREE® (setmelanotide) for Bardet-Biedl and Alström Syndromes

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[{"type":"text","content":"BOSTON, Oct. 14, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company committed to transforming the care of people living with rare genetic diseases of obesity, today announced that it has submitted its Type II variation application to the European Medicines Agency (EMA) for IMCIVREE® (setmelanotide) for the treatment of obesity and control of hunger in adult and pediatric patients six years of age and older with Bardet-Biedl syndrome (BBS) or Alström syndrome. “This marks an important milestone toward our goal of delivering IMCIVREE globally to patients with BBS and, ultimately, many other rare genetic diseases of obesity,” said David Meeker, M.D., Chairman, President and Chief Executive Officer of Rhythm. “IMCIVREE achieved clinically meaningful and statistically significant results in our Phase 3 trial in BBS and provided evidence of marked and sustained weight loss in patients with Alström syndrome treated in our Phase 2 and 3 trials. Based on these data, we believe IMCIVREE will be the first medicine to effectively address the severe, early-onset obesity and hyperphagia that characterize these diseases. We look forward to working closely with regulatory authorities in the European Union to deliver IMCIVREE to these additional populations.” “The BBS community in the EU is particularly well established, with more than 1,500 patients diagnosed and being cared for at academic centers,” said Yann Mazabraud, Executive Vice President, Head of International of Rhythm. “Importantly, many of these patients present with the severe obesity and hyperphagia that treatment with IMCIVREE is designed to address. We are eager to continue our targeted efforts to increase understanding of BBS and the potential benefits of IMCIVREE and, if authorised, look forward to bringing this treatment to market quickly as a key step toward transforming the care of people living with rare genetic diseases of obesity.” The EMA submission is based on data from Rhythm’s pivotal Phase 3 clinical trial of setmelanotide in patients with BBS or Alström syndrome. As previously reported, the study met its primary endpoint and all key secondary endpoints, with statistically significant and clinically meaningful reductions in weight and hunger at 52 weeks on therapy. All patients who met the primary endpoi...

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