Rhythm Pharmaceuticals Receives Positive CADTH Reimbursement Recommendation for IMCIVREE® (setmelanotide)
-- CADTH recommends reimbursement for weight management in adult and pediatric patients six years of age and older with obesity due to Bardet-Biedl syndrome (BBS) --
-- Recommendation based on demonstrated clinical benefit in Phase 3 trial --
“This positive CADTH recommendation will be welcome news for the patients and families living with hyperphagia, which is a pathological and insatiable hunger, and the severe obesity that is often associated with BBS,” said Prof.
CADTH’s recommendation is based on results from Rhythm’s Phase 3 trial that demonstrated treatment with setmelanotide resulted in meaningful clinical benefit in patients 6 years of age and older with obesity due to BBS. Data showed that treatment with setmelanotide for 52 weeks resulted in a clinically meaningful reduction in weight-related parameters, such as total body weight and body mass index (BMI), and the results were supported by the exploratory comparative 14-week placebo-controlled outcomes. Consistent with prior clinical experience, setmelanotide was generally well tolerated. Treatment-emergent adverse events (TEAEs) included mild injection site reactions and nausea.
BBS is a rare genetic disease with an estimated prevalence of 1 in 100,000 to 160,000 in the populations of
IMCIVREE® (setmelanotide) is the first and only therapy approved in
“This recommendation represents a significant milestone for Canadian patients living with obesity due to BBS. We appreciate CADTH’s recommendation and their recognition of the rare genetic nature of BBS, the unmet needs of these patients and that IMCIVREE is the only available therapy that targets the underlying disease mechanism of BBS,” said
About Rhythm Pharmaceuticals
Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) diseases. Rhythm’s lead asset, IMCIVREE (setmelanotide) is approved by the U.S. Food and Drug Administration (FDA), and authorized by the European Commission (EC) and the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) for use in accordance with product labeling. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare MC4R pathway diseases, as well as a preclinical suite of investigational candidates for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.
To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337. You can report any suspected side effects associated with the use of health products to
Please see the Product Monograph at https://rhythmtx.ca/wp-content/uploads/2023/05/IMCIVREE-Product-Monograph-EN.pdf for complete safety information.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy, and regulatory and clinical progress of setmelanotide, the potential benefits of and our expectations surrounding the CADTH reimbursement recommendation, and our business strategy and plans, including regarding commercialization of IMCIVREE in
Executive Director, Investor Relations and Corporate Communications
Berry & Company Public Relations
Source: Rhythm Pharmaceuticals, Inc.