Rhythm Pharma's Imcivree Label Expansion Under Review in US and EU

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