Rhythm Pharmaceuticals announces FDA approval of Imcivree (setmelanotide) for use in patients with Bardet-Biedl syndrome

Rhythm Pharmaceuticals

16 June 2022 - Approval based on Phase 3 trial results that demonstrated statistically significant reductions in weight and hunger in patients with Bardet-Biedl syndrome.

Rhythm Pharmaceuticals today announced that the U.S. FDA has approved the Company’s supplemental new drug application for Imcivree (setmelanotide), a melanocortin 4 receptor agonist, for patients with Bardet-Biedl syndrome.

Read Rhythm Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Orphan drug