The U.S. Food and Drug Administration approved Imcivree (setmelanotide) 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 (POMC) deficiency, proprotein subtilisin/kexin type 1 (PCSK1) deficiency, and leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes considered pathogenic (causing disease), likely pathogenic, or of uncertain significance, according to an FDA press release.
Imcivree is the first FDA-approved treatment for these genetic conditions.
The press release states: "Imcivree is not approved for obesity due to suspected POMC, PCSK1, or LEPR deficiency with variants classified as benign (not causing disease) or likely benign or other types of obesity, including obesity associated with other genetic syndromes and general (polygenic) obesity.
"Imcivree works by activating areas in the brain that regulate appetite and fullness, causing patients with specific defects in these areas of the brain not to eat as much and to lose weight. The drug also increases resting metabolism (the number of calories the body burns at rest), which can contribute to weight loss. While Imcivree leads to weight loss in patients with obesity associated with these conditions, it does not treat the genetic defects that cause the conditions or other symptoms or signs.
"Imcivree was evaluated in two 1-year studies.
"The effectiveness of Imcivree was assessed in 21 patients, 10 in the first study and 11 in the second.
"FDA granted orphan disease designation, Breakthrough Therapy designation, and Priority Review for this drug application. FDA granted the approval of Imcivree to Rhythm Pharmaceutical, Inc. "
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