Rhythm Pharmaceuticals Announces FDA Acceptance for - GlobeNewswire
Rhythm Pharmaceuticals seeks FDA approval to expand IMCIVREE® (setmelanotide) use for treating obesity in children as young as 2 with Bardet-Biedl syndrome or POMC/LEPR deficiency, with a PDUFA goal date of December 26, 2024. The sNDA is based on Phase 3 trial data showing efficacy in reducing BMI in young children.
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Rhythm Pharmaceuticals Announces FDA Acceptance for - GlobeNewswire
Rhythm Pharmaceuticals seeks FDA approval to expand IMCIVREE® (setmelanotide) use for treating obesity in children as young as 2 with Bardet-Biedl syndrome or POMC/LEPR deficiency, with a PDUFA goal date of December 26, 2024. The sNDA is based on Phase 3 trial data showing efficacy in reducing BMI in young children.