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# FDA Approves Rhythm Pharma sNDA for Imcivree
- URL: https://www.fdaweb.com/fda-approves-rhythm-pharma-snda-for-imcivree/
- Published: 2022-06-16T12:00:00.000Z
- Updated: 2026-09-14T17:48:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152096

FDA has approved a Rhythm Pharmaceuticals supplemental NDA for [Imcivree](https://www.accessdata.fda.gov/drugsatfda%5Fdocs/label/2022/213793s001lbl.pdf?ref=fdaweb.com) (setmelanotide) injection, indicated for chronic weight management in adult and pediatric patients six years of age and older with obesity due to Bardet-Biedl Syndrome (BBS). The therapy was originally approved 11/2020 for chronic weight management in adult and pediatric patients six years of age and older with obesity due to the genetic conditions proopiomelanocortin, proprotein convertase subtilisin/kexin type 1, or leptin receptor deficiency, which cause severe obesity that begins at an early age.

Approval of the sNDA is based on data [evaluated](https://clinicaltrials.gov/ct2/show/NCT03746522?ref=fdaweb.com) in a 66-week trial that enrolled 44 patients with a clinical diagnosis of BBS and obesity, according to an [agency release](https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-weight-management-patients-bardet-biedl-syndrome-aged-6-or-older?utm%5Fmedium=email&utm%5Fsource=govdelivery). “After 52 weeks of treatment, patients taking Imcivree lost, on average, 7.9% of their BMI \[body mass index\],” it says. “Sixty-one percent (61%) of patients lost 5% or more of their BMI, and 39% lost 10% or more of their BMI.”