FDA grants breakthrough therapy designation to setmelanotide for hypothalamic obesity
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The FDA has granted breakthrough therapy designation to setmelanotide for patients with hypothalamic obesity, according to a company press release.
“Breakthrough therapy designation marks a meaningful step in our effort to advance setmelanotide as quickly as possible for hypothalamic obesity, reflecting both the strength of our interim phase 2 data and the significant need for a novel therapy that can transform the care of patients living with this rare, acquired obesity,” David Meeker, MD, chair, president and CEO of Rhythm Pharmaceuticals, said in the release.
Previously, setmelanotide, a melanocortin-4 receptor agonist, received breakthrough designation while being developed for treatment of patients with Bardet-Biedl syndrome and proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 and leptin receptor deficiencies.
The current breakthrough therapy designation was granted based on results from a phase 2 16-week clinical study of setmelanotide that demonstrated that all 11 patients achieved a decrease of more than 5% in their BMI with a mean reduction of 17.2% at 16 weeks.
The FDA’s breakthrough therapy designation will expedite the development and review of setmelanotide to address hypothalamic obesity, which is a rare form of extreme obesity occurring after damage to the hypothalamic region of the brain.
“We look forward to initiating a phase 3 trial evaluating setmelanotide in hypothalamic obesity in early 2023,” Meeker said.
Full data from the phase 2 setmelanotide trial will be presented at ObesityWeek 2022 in a late-breaking poster presentation.
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