Rhythm gets priority review for weight loss med application

 FDA sets PDUFA goal date of March 16, 2022

Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide), a melanocortin-4 receptor (MC4R) agonist, for patients with Bardet-Biedl syndrome (BBS) or Alström syndrome. The FDA granted Priority Review of the sNDA and assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2022.

“The acceptance for filing of our supplemental application by the FDA marks an important step in our efforts to address the unmet needs and bring IMCIVREE to patients and families living with Bardet-Biedl syndrome and Alström syndrome,” said Linda Shapiro, M.D., Ph.D., Chief Medical Officer of Rhythm Pharmaceuticals. “The FDA’s decision to grant Priority Review to the application aligns with our belief in the potential of IMCIVREE to deliver clinically meaningful and statistically significant reductions in body weight and hunger for patients with BBS and Alström syndrome while also substantially improving quality of life for these patients and their families.”

https://finance.yahoo.com/news/rhythm-pharmaceuticals-announces-fda-acceptance-124500887.html