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Rhythm Pharmaceuticals Announces Submission of Marketing Authorization Application to the European Medicines Agency for Setmelanotide in POMC and LEPR Deficiency Obesities
-- Company also announces positive data from eight supplemental patients, including four pediatric patients, enrolled in pivotal Phase 3 clinical trials; all
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- Company also announces positive data from eight supplemental patients, including four pediatric patients, enrolled in pivotal Phase 3 clinical trials; all achieved primary endpoint of 10 percent weight loss --\n -- Setmelanotide was well-tolerated in long-term extension study with continued clinical benefit and durable weight loss observed at up to three years on therapy -- BOSTON, July 01, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, today announced that it has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity. The company has been granted accelerated assessment of the MAA, which potentially shortens review time by the Committee for Medicinal Products for Human Use (CHMP). In conjunction with this submission, Rhythm announced additional positive data from eight supplemental patients, including four pediatric patients, enrolled in its two pivotal Phase 3 clinical trials for POMC and LEPR deficiency obesities, as well as updated data from its long-term extension study of setmelanotide in patients with POMC or LEPR deficiency obesity. Rhythm included these data in its MAA submission package to the EMA. “We are pleased to have submitted our MAA for setmelanotide for the treatment of POMC and LEPR deficiency obesities, another step toward our goal of delivering setmelanotide to patients with these ultra-rare disorders,” said Murray Stewart, M.D., Chief Medical Officer of Rhythm. “We are also excited to report additional data that provide further evidence regarding setmelanotide’s potential impact in driving weight loss in patients with POMC or LEPR deficiency obesity. In particular, we are encouraged to see therapeutic activity in children and adolescents among our supplemental patients. These chronic disorders often arise in childhood, with patients suffering from severe obesity and insatiable hunger beginning at a very young age. By intervening earlier, we believe it may be possible to reduce body weight and hunger significantly, ther...