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Rhythm May Have Data To Add Indication To Imcivree’s Label

 
• By Joseph Haas

Drug already approved for multiple rare genetic disorders of obesity shows significant weight-loss reduction in Bardet-Beidl syndrome, but not in the smaller indication of Alström syndrome.

Rhythm's latest data could lead to an important label expansion

Rhythm Pharmaceuticals, Inc., focused on rare genetic diseases of obesity, unveiled more Phase III data for its lead candidate setmelanotide on 22 December, but the results were somewhat mixed because the study enrolled patients with two different MCR4-mediated diseases and most of the positive data, including for the primary endpoint, came from one disease population.

Setmelanotide, an agonist of the melanocortin-4 receptor, obtained US Food and Drug Administration approval on 27 November for obesity caused by deficiencies of the proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin (LEPR) receptor, under the brand name Imcivree. (Also see "Keeping Track: Orladeyo, Danyelza, Imcivree Bring CDER 2020 Novel Approval Count Even With Full-Year 2019" - Pink Sheet, 4 December, 2020

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