FDA OKs Rhythm Pharma's Imcivree for weight management in obesity

 

• The FDA has approved Rhythm Pharmaceuticals' (NASDAQ: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 hosted conference call today at 9:30 a.m. ET to discuss the FDA approval of Imcivree.
• https://seekingalpha.com/news/3639653-fda-oks-rhythm-pharmas-imcivree-for-weight-management-in-obese-patients