Posted by Michael Wonder on 03 Sep 2017
European Commission approves expanded use of Mimpara (cinacalcet) for the treatment of secondary hyperparathyroidism in children with end-stage renal disease on dialysis
31 August 2017 - Amgen today announced that the European Commission has granted marketing authorisation of a paediatric formulation (granules in capsule for opening) of Mimpara (cinacalcet) for the treatment of secondary hyperparathyroidism in children aged three years and older with end‑stage renal disease on maintenance dialysis therapy in whom secondary hyperparathyoidism is not adequately controlled with standard of care therapy.
The European Commission (EC) approved Mimpara based on studies Amgen began in 2007 to assess the use of Mimpara in paediatric patients with secondary hyperparathyroidism, who have very few treatment options.
Approval from the EC grants a centralised marketing authorisation with unified labelling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area, will take corresponding decisions on the basis of the decision of the EC.
