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Rhythm Pharmaceuticals Launches IMCIVREE® (setmelanotide) in Germany for the Treatment of Obesity and Control of Hunger Associated with POMC or LEPR Deficiency
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 IMCIVREE® (setmelanotide) is now available to patients in Germany. IMCIVREE, a melanocortin-4 receptor (MC4R) agonist, last year received marketing authorization from the European Commission 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 excited to make IMCIVREE available to treat patients in Germany living with the hyperphagia and severe obesity caused by these rare MC4R pathway diseases,” said Yann Mazabraud, Executive Vice President, Head of International at Rhythm. “We thank the German authorities for their recognition of the need for a therapy to treat obesity and control hunger due to POMC and LEPR deficiencies as we work to transform the lives of patients living with these diseases.” The German Federal Joint Committee (G-BA) earlier this year voted to exclude IMCIVREE from its lifestyle exemption list for POMC or LEPR deficiency obesity. In Germany, drugs classified as lifestyle drugs, which include those designed to effect weight loss, smoking cessation or hair loss, are not eligible for reimbursement. IMCIVREE, which is the first precision medicine designed to induce weight loss and control of hunger to receive such an exemption, now is eligible for national coverage and reimbursement. About Rhythm PharmaceuticalsRhythm is a commercial-stage biopharmaceutical company committed transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases. Rhythm’s precision medicine, IMCIVREE (setmelanotide), 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 POMC, PCSK1 or LEPR deficiency confirmed by genetic testing, or patients with a clinical diagnosis of Bardet-Biedl syndrome (BBS). The Europ...