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# Rhythm Gets Expanded Imcivree Indication
- URL: https://www.fdaweb.com/rhythm-gets-expanded-imcivree-indication/
- Published: 2025-01-03T12:00:00.000Z
- Updated: 2026-09-14T14:49:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158405

FDA has approved an expanded indication for Rhythm Pharmaceuticals’ Imcivree (setmelanotide) to include children as young as age 2\. A company [statement](https://ir.rhythmtx.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-fda-approval-imcivreer-0?ref=fdaweb.com) says Imcivree is indicated to reduce excess body weight and Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency.

“Results from clinical trials demonstrate that setmelanotide delivers significant and sustained reductions in measures of weight and hunger,” Rhythm says…. “The most common adverse events are skin hyperpigmentation, injection site reactions, diarrhea, nausea, and headache.”

Imcivree was first approved in 11/2020 for patients age 6 and older with POMC, PCSK1, or LEPR deficiencies. The indication was expanded in 6/2022 for use in patients with BBS.