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Rhythm Pharmaceuticals Reports the US FDA’s Approval of Imcivree (Setmelanotide) for Patients as Young as 2 Years Old

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Rhythm Pharmaceuticals

Rhythm Pharmaceuticals Reports the US FDA’s Approval of Imcivree (Setmelanotide) for Patients as Young as 2 Years Old

Shots:

  • The US FDA has approved the indication expansion of Imcivree to add children as young as 2yrs. of age
  • Setmelanotide significantly reduced weight & hunger across clinical evaluations, with common AEs being skin hyperpigmentation, injection site reactions, diarrhea, nausea & headache. The P-III (VENTURE) study results were published in The Lancet Diabetes & Endocrinology (Nov 2024)
  • Imcivree is developed for excess weight reduction & sustaining for long-term among patients (≥2yrs.) with Bardet-Biedl syndrome (BBS) or monogenic obesity due to POMC, PCSK1, or LEPR deficiencies

Ref: Rhythm Pharmaceuticals | Image: Rhythm Pharmaceuticals

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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