Posted by Michael Wonder on 24 Feb 2022
Rhythm Pharmaceuticals announces FDA extension of review period for Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome and Alström syndrome
24 February 2022 - FDA sets updated PDUFA goal date of 16 June 2022.
Rhythm Pharmaceuticals today announced that the U.S. FDA has extended by three months the review period for the supplemental new drug application for Imcivree (setmelanotide) for the treatment of obesity and control of hunger in adult and paediatric patients 6 years of age and older with Bardet-Biedl syndrome or Alström syndrome.
