Rhythm Pharmaceuticals Announces European Commission Authorization of IMCIVREE® (setmelanotide)▼ for the Treatment of Obesity and Control of Hunger Associated with POMC, PCSK1 and LEPR Deficiency

6 min read
First-ever authorized treatment option in the European Union for these rare genetic diseases of obesityBOSTON, July 23, 2021 (GLOBE NEWSWIRE) -- Rhythm...
First-ever authorized treatment option in the European Union for these rare genetic diseases of obesity

BOSTON, July 23, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company committed to transforming the care of people living with rare genetic diseases of obesity, today announced that the European Commission (EC) has granted marketing authorization to IMCIVREE (setmelanotide) in the European Union (EU) for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above.

"Rhythm's Phase 3 trials confirmed that treatment with IMCIVREE may deliver clinically meaningful impacts on obesity and severe hunger or hyperphagia. Many patients enrolled in these studies experienced weight loss of a magnitude that is unprecedented in the natural history of rare genetic diseases of obesity," said Martin Wabitsch, M.D., professor of medicine and head of the Division of Pediatric Endocrinology and Diabetes at Ulm University Medical Center in Germany. "With this authorization, we are reminded of the importance of genetic testing, so that we can identify and properly diagnose patients with POMC, PCSK1 or LEPR deficiency obesity and offer eligible patients IMCIVREE, a pharmacological therapy designed to address the underlying cause of their disease."

"With this authorization now in the EU, IMCIVREE becomes the first and only treatment option available to patients in EU countries and other territories including Northern Ireland to address the underlying cause of obesities driven by certain genetic defects in the melanocortin-4 (MC4) receptor pathway," said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. "This marks an important milestone for…
Rhythm Pharmaceuticals, Inc.
Read full article