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Rhythm Pharmaceuticals Announces IMCIVREE® (setmelanotide) Granted Marketing Authorization by European Commission for Treatment of Obesity and Control of Hunger in Bardet-Biedl Syndrome
-- Setmelanotide now FDA-approved and EC-authorized for Bardet-Biedl syndrome (BBS) -- -- EC authorization for BBS makes Rhythm eligible to receive second
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- Setmelanotide now FDA-approved and EC-authorized for Bardet-Biedl syndrome (BBS) -- -- EC authorization for BBS makes Rhythm eligible to receive second $37.5M tranche under Revenue Interest Agreement with HealthCare Royalty -- -- Health Canada grants Priority Review status for new drug submission for setmelanotide for treatment of obesity and control of hunger in BBS and biallelic POMC, PCSK1 or LEPR deficiencies -- BOSTON, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases, today announced that the European Commission (EC) has expanded the marketing authorization for IMCIVREE® (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) in adult and pediatric patients 6 years of age and older. “Patients and families have long endured a significant need for a therapy to address the burdens of hyperphagia and severe obesity often associated with BBS,” said Philip Beales, M.D., University College London, UCL Great Ormond Street Institute of Child Health. “Having new treatment options available can help address the physical and emotional aspects of this devastating disease, offering patients and their families relief and improved quality of life.” BBS is a rare genetic disease that affects approximately 2,500 people in the European Union (EU) and United Kingdom (UK). People living with BBS may experience insatiable hunger, also known as hyperphagia, and severe obesity beginning early in life. Approximately 1,500 patients have been diagnosed with BBS and are now being cared for at academic settings in the EU and UK. Under the terms of the Revenue Interest Financing Agreement with HealthCare Royalty Partners announced on June 16, 2022, Rhythm is now eligible to receive an additional investment of $37.5 million following EC marketing authorization for setmelanotide for BBS. Rhythm had received an initial investment amount of $37.5 million from HealthCare Royalty as a result of the approval of setmelanotide by the U.S. Food and Drug Administration (FDA), and the Company remains eligible for an additional investment...