Breakthrough Tx Status Granted to Treatment for Rare Obesity Disorder

The FDA has granted setmelanotide (Rhythm) Breakthrough Therapy designation
The FDA has granted setmelanotide (Rhythm) Breakthrough Therapy designation

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.


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