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
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