Rhythm Pharmaceuticals Announces Approval Reimbursement Decision In Italy For IMCIVREE For The Treatment Of Obesity And Control Of Hunger In Bardet-Biedl Syndrome

Author: Benzinga Newsdesk | February 07, 2024 09:25am

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.

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