Rhythm announced that the Food and Drug Administration (FDA) has granted setmelanotide Breakthrough Therapy designation for the treatment of pro-opiomelanocortin (POMC) deficiency obesity, and Orphan Drug designation for the treatment of Prader-Willi Syndrome (PWS).

POMC deficiency obesity is a rare, genetic disorder that results in extreme and unrelenting appetite and obesity due to impaired melanocortin-4 (MC4) pathway function. PWS is a rare, life‑threatening disease characterized by severe hyperphagia, an overriding physiological drive to eat, leading to severe obesity and other complications. Currently, there is no approved treatment for PWS-associated obesity and hyperphagia.

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Setmelanotide is currently in two Phase 2 clinical trials for the treatment of POMC deficiency obesity and PWS, two rare genetic disorders of obesity caused by MC4 pathway deficiencies.

Setmelanotide is a novel, potent, first-in-class melanocortin-4 receptor (MC4R) agonist.

For more information visit Rhythmtx.com.