EU CHMP recommends approval of pediatric formulation of Mimpara (cinacalcet) in secondary hyperparathyroidism- Amgen
Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of a pediatric formulation (granules in capsule for opening) of Mimpara (cinacalcet). Approval was recommended for the treatment of secondary hyperparathyroidism (HPT) in children aged three years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy. The Marketing Authorization Application for Mimpara was based on studies Amgen began in 2007 to assess the use of Mimpara in pediatric secondary HPT patients, who have very few treatment options.
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