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# Regulatory Review Period for Imcivree
- URL: https://www.fdaweb.com/regulatory-review-period-for-imcivree/
- Published: 2022-07-01T12:00:00.000Z
- Updated: 2026-09-14T17:50:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152219

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Rhythm Pharmaceuticals’ Imcivree (setmelanotide acetate), indicated for chronic weight management in adult and pediatric patients six years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSKI, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance. The review period is 3,304 days, of which 3,060 days occurred during the testing phase and 244 days occurred during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-07-01/pdf/2022-14134.pdf?ref=fdaweb.com).