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Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE™ (setmelanotide) as First-ever Therapy for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency
-- Indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- Indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency confirmed by genetic testing --\n\n \n \n \n \n \n \n \n \n \n \n \n Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE™(setmelanotide) as First-ever Therapy for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency\n \n \n \n \n \n \n \n \n\n -- Approval supports company’s approach to address rare genetic diseases of obesity associated with an impaired MC4 receptor pathway -- -- People living with these rare genetic diseases of obesity struggle with insatiable hunger and excessive weight gain beginning at a young age -- -- Approval based on data from two 52-week open-label trials that demonstrated clinically meaningful and statistically significant weight loss and reduction of hunger -- -- Rare Pediatric Disease Priority Review Voucher issued to Rhythm by FDA -- -- Company to host conference call today at 9:30 a.m. ET -- BOSTON, Nov. 27, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, announced today that the U.S. Food & Drug Administration (FDA) has approved IMCIVREE™ (setmelanotide) for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing. With this approval, IMCIVREE becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. “Our first new drug approval is a major milestone for Rhythm, and we look forward to delivering on the promise of IMCIVREE for patients suffering with obesity due to POMC, PCSK1 or LEPR deficiency,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. “With IMCIVREE, we are advancing a first-in-class, precision medicine that is designed to directly address the underlying cause of obesities driven by genetic deficits in the melanocortin-4 (MC4) receptor pathway.” Obesity due to POMC, PCSK1 or LEPR deficiency are ultra-rare diseases caused by variants in POMC, PCSK1 or LEPR genes that impair the MC4 receptor pathway...