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Rhythm Pharmaceuticals Announces Health Canada Approval of IMCIVREE® Setmelanotide Injection for Weight Management in Bardet-Biedl Syndrome or Genetically-confirmed Biallelic POMC, PCSK1, or LEPR Deficiency
-- First and only approved therapy in Canada that targets genetic impairment in the MC4R pathway - a root cause of early-onset, severe obesity in these
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- First and only approved therapy in Canada that targets genetic impairment in the MC4R pathway - a root cause of early-onset, severe obesity in these patients – -- Approval granted following a Priority Review by Health Canada – BOSTON, May 08, 2023 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company, today announced that Health Canada has approved IMCIVREE® (setmelanotide solution for subcutaneous injection) for weight management in adult and pediatric patients 6 years of age and older with obesity due to Bardet-Biedl syndrome (BBS) or genetically-confirmed biallelic pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency due to variants interpreted as pathogenic, likely pathogenic, or of uncertain significance. Please consult the IMCIVREE product monograph available at www.rhythmtx.ca. “We are pleased to announce Health Canada’s approval of IMCIVREE, marking a significant expansion of our footprint in North America and another important step forward in our efforts to deliver our precision medicine to people worldwide,” said Jennifer Chien, Executive Vice President, Head of North America for Rhythm. “We will leverage insights from our experience with launches in the U.S. and Europe to support the strong team we have in Canada and look forward to making IMCIVREE commercially available in Canada in the months ahead.” The early-onset obesity in patients with BBS and POMC, PCSK1 and LEPR deficiencies are caused by genetic variants that result in impairments in the melanocortin-4 receptor (MC4R) pathway, a system in the hypothalamus that regulates hunger, satiety, and energy expenditure. IMCIVREE is the first and only therapy approved in Canada for weight management in these patients following a Priority Review, which shortened the review process and was granted based on the serious nature of these conditions and lack of treatment options in Canada. IMCIVREE is not indicated for patients with obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign, or other types of obesity not related to POMC, PCSK1 or LEPR deficiency, or BBS including obesity associated with other genetic syndromes and general (polygenic) obesity, as it would not be exp...