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# FDA Extends Imcivree sNDA After Major Amendment
- URL: https://www.fdaweb.com/fda-extends-imcivree-snda-after-major-amendment/
- Published: 2022-02-24T12:00:00.000Z
- Updated: 2026-09-14T17:34:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151231

FDA has extended by three months its review of a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) for treating obesity and control of hunger in adult and pediatric patients six years of age and older with Bardet-Biedl Syndrome (BBS) or Alström syndrome. The new user fee review action date is 6/16.

The company says that the agency earlier this month requested additional subgroup analyses of the clinical efficacy data from Rhythm’s Phase 3 pivotal trial in BBS and Alström syndrome. It notes that no new data were requested, but the request was determined to be a “major amendment” that requires additional time to review.

Imcivree was approved n 2020 for chronic weight management (weight loss and weight maintenance for at least one year) in patients six years and older with obesity due to three rare genetic conditions: pro-opiomelanocortin deficiency, proprotein subtilisin/kexin type 1 deficiency, and leptin receptor deficiency confirmed by genetic testing. Rhythm says the drug works by activating areas in the brain that regulate appetite and fullness, adding that it also increases resting metabolism, which can contribute to weight loss.