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Rhythm Receives the US FDA’s Approval for Imcivree (setmelanotide) sNDA to Treat Bardet-Biedl Syndrome

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Rhythm Receives the US FDA’s Approval for Imcivree (setmelanotide) sNDA to Treat Bardet-Biedl Syndrome

Shots:

  • The approval was based on the P-III trial to evaluate Imcivree vs PBO in adult & pediatric patients aged ≥6yrs. with monogenic or syndromic obesity due to POMC, PCSK1, LEPR deficiency, or BBS
  • The trial met its 1EPs & 2EPs i.e., reductions in weight & hunger @52wks., mean percent change in BMI was -7.9% without requirements for diet & exercise; PBO-adjusted change in BMI was -4.5% @14wk. (-4.6% vs -0.1%); mean change in hunger score was -2.1 @52wks. in patients aged ≥12yrs., were generally well-tolerated
  • The US FDA has issued a CRL for setmelanotide’ sNDA in ALMS & the company plans to advance the therapy for ALMS in the US along with a clinical research program for setmelanotide in patients with obesity

Ref: Globe Newswire | Image: Genentech

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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