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Rhythm Pharma Announces FDA Approval Of IMCIVREE - Quick Facts

Rhythm Pharmaceuticals, Inc. (RYTM) announced the FDA has approved IMCIVREE (setmelanotide) for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency confirmed by genetic testing.

The FDA also issued a Rare Pediatric Disease Priority Review Voucher to Rhythm. The PRV can be redeemed to receive priority review for any subsequent marketing application or sold or transferred to other companies for their programs.

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