AInvest Newsletter
Daily stocks & crypto headlines, free to your inbox
_6ff029a61766633234293.png?format=webp&width=1186&height=250)
Rhythm Pharma's Imcivree Label Expansion Under Review in US and EU
ByAinvest
Thursday, Aug 21, 2025 8:39 am ET1min read
Rhythm Pharmaceuticals has announced that the FDA and European Medicines Agency have accepted for review a potential label expansion for its obesity therapy, Imcivree. The expansion would allow for the use of setmelanotide in more patients. Rhythm Pharmaceuticals is a biopharmaceutical company focused on treating rare genetic disorders, including obesity.
Rhythm Pharmaceuticals, Inc. (RYTM) has announced that both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review a potential label expansion for its obesity therapy, setmelanotide, marketed as Imcivree. This expansion aims to include more patients, specifically those with acquired hypothalamic obesity, a rare and challenging form of obesity.The FDA has granted Priority Review to the supplemental New Drug Application (sNDA) for setmelanotide, setting a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2025. The EMA has also validated a Type II variation submission to the Marketing Authorization Application (MAA) for setmelanotide, with the review expected to begin on August 16, 2025.
Setmelanotide is a melanocortin-4 receptor (MC4R) agonist, previously approved for obesity due to Bardet-Biedl syndrome and POMC, PCSK1, or LEPR deficiencies. The potential label expansion is backed by data from Rhythm's pivotal Phase 3 TRANSCEND trial, which demonstrated a statistically significant 19.8% placebo-adjusted decline in body mass index (BMI) among patients with acquired hypothalamic obesity.
The company plans to host a "Commercial Readiness for Acquired Hypothalamic Obesity" event for investors and analysts on September 24, 2025, in Boston, to review U.S. launch plans and discuss the urgent need to treat patients with acquired hypothalamic obesity.
References:
[1] https://www.nasdaq.com/articles/fda-accepts-rhythm-pharma-snda-setmelanotide-treat-acquired-hypothalamic-obesity
[2] https://seekingalpha.com/news/4487884-rhythm-pharma-label-expansion-requests-undergo-us-eu-reviews
[3] https://www.biospace.com/press-releases/rhythm-pharmaceuticals-announces-fda-acceptance-of-snda-for-setmelanotide-in-acquired-hypothalamic-obesity
Ainvest News articles are AI-generated using advanced large language model (LLM) technology designed to analyze and synthesize publicly available data and news. While AI tools assist in producing initial drafts and insights, all AI generated content published on Ainvest is subject to comprehensive human editorial review before publication. A designated human editor reviews, verifies, and approves each article for factual accuracy, coherence, and compliance with AInvest Fintech Inc’s editorial and disclosure standards.
Despite these review procedures, the information provided may still contain inaccuracies, incomplete data, or time sensitive references due to the inherent limitations of AI generated analysis and evolving changes. The material is provided strictly for informational and educational purposes and does not constitute personalized investment, legal, or financial advice. Readers should independently verify all facts, figures, and statements before making any decision based on this content.
AInvest Fintech Inc. its affiliates, and partners accept no liability or responsibility for any direct or consequential losses arising from reliance on this content. All articles and analyses are subject to revision, update, or removal without prior notice to maintain accuracy and integrity in our publications.
Comments
No comments yet