{"id":906284,"date":"2025-11-05T20:02:32","date_gmt":"2025-11-06T01:02:32","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/rhythm-pharmaceuticals-announces-public-reimbursement-for-imcivree-setmelanotide-in-canada-in-five-provinces-and-under-the-federal-non-insured-health-benefits-program\/"},"modified":"2025-11-05T20:02:32","modified_gmt":"2025-11-06T01:02:32","slug":"rhythm-pharmaceuticals-announces-public-reimbursement-for-imcivree-setmelanotide-in-canada-in-five-provinces-and-under-the-federal-non-insured-health-benefits-program","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/rhythm-pharmaceuticals-announces-public-reimbursement-for-imcivree-setmelanotide-in-canada-in-five-provinces-and-under-the-federal-non-insured-health-benefits-program\/","title":{"rendered":"Rhythm Pharmaceuticals Announces Public Reimbursement for IMCIVREE\u00ae (setmelanotide) in Canada in Five Provinces and Under the Federal Non-Insured Health Benefits Program"},"content":{"rendered":"

\nIMCIVREE now publicly covered for weight management due to Bardet-Biedl syndrome (BBS) in Ontario, Alberta, British Columbia, Saskatchewan, Nova Scotia and under NIHB
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BOSTON, Nov. 05, 2025 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that it has entered into Product Listing Agreements in the provinces of Ontario, Alberta, British Columbia, Saskatchewan, Nova Scotia and with the Federal Non-Insured Health Benefits (NIHB) Program for the public reimbursement of IMCIVREE for weight management in eligible adult and pediatric patients aged 6 years and older with clinically or genetically confirmed Bardet-Biedl syndrome (BBS) and obesity.<\/p>\n

\u201cThese listing agreements for IMCIVREE mark a significant milestone for individuals living with obesity due to Bardet-Biedl syndrome,\u201d said Prof. Andrea M. Haqq, M.D., Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta. \u201cPatients and families in these provinces can now access a treatment that addresses a root cause of their disease, offering hope and improved quality of life.\u201d<\/p>\n

IMCIVREE was approved by Health Canada in May 2023 following priority review and was recently added to the common list of new drugs for rare diseases, as part of the Government of Canada’s National Strategy for Drugs for Rare Diseases. The Common Drug List ensures that the National Strategy for Drugs for Rare Diseases<\/em> provides the greatest possible benefit to all patients with rare diseases.<\/p>\n

\u201cThese agreements are an important recognition of the substantial burden of obesity associated with this rare disease,\u201d said Carol Stiff, General Manager, Rhythm Canada. \u201cWe continue to engage with all provinces and territories to work toward equitable access in Canada for all patients living with obesity due to BBS.\u201d<\/p>\n

\n About Bardet-Biedl Syndrome<\/strong>\n <\/p>\n

BBS is a rare autosomal recessive ciliopathy that presents with a variety of symptoms that evolve over time, including hyperphagia, early-onset, severe obesity, visual impairment, polydactyly, genital abnormalities, renal dysfunction, and cognitive impairment.<\/p>\n

\n About Rhythm Pharmaceuticals<\/strong>
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Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm\u2019s lead asset, IMCIVREE\u00ae<\/sup> (setmelanotide), an MC4R agonist is approved by the FDA to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin\/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. Both the European Commission (EC) and the UK\u2019s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists bivamelagon and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm\u2019s headquarters is in Boston, MA.<\/p>\n

\n Setmelanotide Indication<\/strong>
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In Canada, IMCIVREE (setmelanotide solution for subcutaneous injection) is indicated for weight management in adult and pediatric patients 6 years of age and older with obesity due to: Bardet-Biedl syndrome (BBS) 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.<\/p>\n

In\u00a0the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), proprotein convertase subtilisin\/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).<\/p>\n

In the\u00a0European Union\u00a0and the\u00a0United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. In the\u00a0European Union\u00a0and the\u00a0United Kingdom, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.<\/p>\n

\n Limitations of Use<\/strong>\n <\/p>\n

Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective:<\/p>\n