Rhythm Pharmaceuticals Announces Positive Reimbursement Decision in Italy for IMCIVREE (setmelanotide) for the Treatment of Obesity and Control of Hunger in Bardet-Biedl Syndrome

BOSTON, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today announced that the Italian Medicine Agency (AIFA) approved reimbursement (Gazzetta Ufficiale) for IMCIVREE (setmelanotide) for the treatment of obesity and control of hunger associated with Bardet-Biedl syndrome (BBS).

“We are pleased that AIFA has recognized the need for a precision medicine for obesity and control of hunger in BBS,” said Yann Mazabraud, Executive Vice President and Head of International at Rhythm. “Now families in Italy who are affected by this rare neuroendocrine disease will be able to access the first and only treatment option authorized in the European Union, and we look forward to working with the community in Italy to deliver IMCIVREE to patients as we aim to expand access in Europe country-by-country.”

BBS is a rare melanocortin-4 receptor (MC4R) pathway disease with hallmark symptoms of hyperphagia, a pathological hunger that leads to abnormal food-seeking behaviors, and early-onset, severe obesity. BBS is also associated with cognitive impairment, polydactyly, renal dysfunction, hypogonadism, and visual impairment. In Italy, the Company estimates the prevalence of BBS to be between 1/125,000 and 1/160,000, with approximately 200 identified.

AIFA previously approved reimbursement for IMCIVREE for the treatment of obesity and control of hunger associated with biallelic proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or biallelic leptin receptor (LEPR) deficiency.

About Rhythm Pharmaceuticals
Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing, or patients with a clinical diagnosis of Bardet-Biedl syndrome (BBS). Both the European Commission (EC) and the UK’s 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 6 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as RM-718 and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.