Business
Rhythm Pharmaceuticals Announces European Commission Expands ▼IMCIVREE® (setmelanotide) Marketing Authorization to include Children as Young as 2 Years Old
IMCIVREE now authorized as treatment of obesity and control of hunger in adult patients and pediatric patients 2 years old or older with Bardet Biedl syndrome
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"IMCIVREE now authorized as treatment of obesity and control of hunger in adult patients and pediatric patients 2 years old or older with Bardet Biedl syndrome or POMC, PCSK1, or LEPR deficiency\nBOSTON, July 31, 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 European Commission (EC) expanded the marketing authorization for IMCIVREE® (setmelanotide) to include children between 2 and younger than 6 years old with obesity due to Bardet Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. “Today marks what we believe to be an important milestone for European patients with BBS and POMC/LEPR deficiencies ages 2 to 6, who now have the opportunity to address the severe and insatiable hunger and early onset obesity associated with their conditions at an early age,” said Yann Mazabraud, Executive Vice President, Head of International at Rhythm Pharmaceuticals. “Early-onset obesity that goes untreated can manifest in multiple comorbidities and negatively affect quality of life and life expectancy. For the first time, physicians and patients in Europe may have the opportunity to access what we believe is a meaningful treatment option for children as young as 2 years old.” IMCIVREE is the first-ever authorized precision medicine in the European Union for control of hunger and treatment of obesity in adults and children, now as young as 2 years old, living with BBS or POMC, PCSK1, or LEPR deficiency. About Rhythm PharmaceuticalsRhythm 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 wit...