RYTM - Rhythm Pharma granted FDA priority review for label expansion of weight loss drug

Rhythm Pharmaceuticals (NASDAQ:RYTM) has added ~5.4% in the pre-market after announcing that the FDA accepted the company’s supplemental New Drug Application ((sNDA)) for IMCIVREE (setmelanotide) for Bardet-Biedl syndrome (BBS) or Alström syndrome. The regulator has granted Priority Review for the sNDA and set a Prescription Drug User Fee Act (PDUFA) date of March 16, 2022. A melanocortin-4 receptor (MC4R) agonist, IMCIVREE, is currently approved in the U.S. for chronic weight management in patients with obesity due to proopiomelanocortin (POMC). Early this month, Rhythm (RYTM) indicated that the company plans to launch the drug for BBS and Alström syndrome in mid-2022. BBS and Alström syndrome are very rare genetic disorders that affect multiple organs and cause clinical effects such as severe obesity. Approved in the U.S. in Nov. 2020, IMCIVREE generated $1.0M in sales for the company in Q3 2021.

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Rhythm Pharma granted FDA priority review for label expansion of weight loss drug