20 September 2021 - Rhythm Pharmaceuticals today announced that it has completed its supplemental new drug application to the U.S. FDA 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.
The Company also expects to submit a Type II variation marketing authorisation application to the EMA in the fourth quarter of 2021, which also will cover both Bardet-Biedl syndrome and Alström syndrome.
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