Posted by Michael Wonder on 12 May 2017
Rhythm receives expanded FDA breakthrough therapy designation for setmelanotide for rare genetic disorders of obesity
11 May 2017 - Expands upon previous designation for POMC deficiency obesity.
Rhythm today announced that the U.S. FDA has expanded a previously granted breakthrough therapy designation for setmelanotide, the company’s novel melanocortin-4 receptor agonist. The expanded breakthrough therapy designation is for the treatment of obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway (the MC4 pathway), which includes both pro-opiomelanocortin (POMC) and leptin receptor (LepR) deficiency obesity.
The FDA had previously granted BTD to setmelanotide for the treatment of POMC deficiency obesity.
