RYTM - FDA OKs Rhythm Pharma's Imcivree for weight management in obese patients

The FDA has approved Rhythm Pharmaceuticals' (RYTM) Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin ((POMC)), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor ((LEPR)) deficiency confirmed by genetic testing.With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity.The company expects to make Imcivree commercially available in U.S. in Q1 2021. With this approval, the FDA issued a Rare Pediatric Disease Priority Review Voucher to Rhythm. The voucher can be used for accelerated approval of a future application or it can be sold to a third party. Rhythm’s marketing application for setmelanotide to treat people living with obesity is currently under EMA review.The company will host conference call today at 9:30 a.m. ET to discuss the FDA approval of Imcivree.Shares up 4% premarket.

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FDA OKs Rhythm Pharma's Imcivree for weight management in obese patients