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Rhythm Pharmaceuticals Announces that European Commission Authorized Variation for IMCIVREE® (setmelanotide) to Allow for Dosing in Patients with POMC or LEPR deficiency with Renal Impairment
BOSTON, June 22, 2022 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company committed to transforming
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"BOSTON, June 22, 2022 (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) this week authorized a variation for IMCIVREE® (setmelanotide) that allows for dosing in patients with POMC or LEPR deficiency who have mild, moderate or severe renal impairment. IMCIVREE, a melanocortin-4 receptor (MC4R) agonist, last year received marketing authorization from the EC 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 old and older. “We are pleased the EC has recognized the impact IMCIVREE can have on the lives of patients living with hyperphagia and severe obesity caused by rare MC4R pathway diseases,” said David Meeker, M.D., Chairman, President and Chief Executive Officer of Rhythm. “The expansion of the dosing regimen to include patients with renal impairment is an important step in ensuring more patients have access to a therapy that addresses the root cause of these rare genetic diseases.” The EC’s approval of the Company’s renal dosing variation allows for patients aged 6 years and older with POMC or LEPR deficiency and with mild, moderate, or severe renal impairment to be treated with IMCIVREE. There are no dose adjustments for patients with mild or moderate renal impairment and a separate dose titration schedule is provided for patients with severe renal impairment. Treatment is not recommended for patients with end stage renal disease. Rhythm’s Type II variation application to the European Medicines Agency (EMA) for setmelanotide for the treatment of obesity and control of hunger in adult and pediatric patients 6 years old and older with Bardet-Biedl syndrome also is under review. The EMA’s Committee for Medicinal Products for Human Use (CHMP) is anticipated to make its recommendation on this application in the third quarter of 2022. The amendment for renal impairment dosing is being considered with the BBS application, as well. About Rhythm PharmaceuticalsRhythm is a commercial-stage bi...