Rhythm Receives the US FDA’s Breakthrough Therapy Designation for Setmelanotide to Treat Hypothalamic Obesity
Shots:
- The US FDA has granted the BTD for setmelanotide to treat hypothalamic obesity. The designation was based on the results from a 16wk. P-II clinical study of setmelanotide
- The interim results as reported in July 2022 with preliminary data showed that all 11 evaluable patients achieved a BMI reduction of ≥5% with a mean reduction in BMI of 17.2% @16wk. The P-III trial of setmelanotide is expected to be initiated in early 2023 for hypothalamic obesity
- Setmelanotide is an MC4R agonist & was marketed as Imcivree. Additionally, the therapy has also received BTD for Bardet-Biedl syndrome and POMC, PCSK1, and LEPR deficiencies
Ref: Rhythm | Image: Rhythm
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