Posted by Michael Wonder on 14 Oct 2021
Rhythm Pharmaceuticals completes submission of type II variation application to the European Medicines Agency for Imcivree (setmelanotide) for Bardet-Biedl and Alström syndromes
14 October 2021 - Rhythm Pharmaceuticals today announced that it has submitted its type II variation application to the EMA for Imcivree (setmelanotide) for the treatment of obesity and control of hunger in adult and paediatric patients six years of age and older with Bardet-Biedl syndrome or Alström syndrome.
The EMA submission is based on data from Rhythm’s pivotal Phase 3 clinical trial of setmelanotide in patients with Bardet-Biedl syndrome or Alström syndrome.
