✕
☰

Obesity drug given breakthrough therapy designation by FDA

by

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to Rhythm’s setmelanotide

Setmelanotide is a melanocortin-4 receptor (MC4R) agonist for the treatment of pro-opiomelanocortin (POMC) deficiency obesity.

This drug is in Phase 2 clinical trials for the treatment of rare genetic disorders of obesity caused by MC4 pathway deficiencies. 

BTD is granted by the FDA to expedite the development and review of therapeutics to treat serious or life-threatening conditions for which preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement on at least one clinically significant endpoint over existing therapies.

Keith Gottesdiener, CEO of Rhythm, said: "Patients with POMC deficiency obesity have extreme and unrelenting appetite and obesity because of impaired function in the MC4 pathway.

“We are pleased to receive this breakthrough designation and look forward to working closely with the FDA as we continue to advance the setmelanotide program."

Back to topbutton