The FINANCIAL — Amgen on August 31 announced that the European Commission (EC) has granted Marketing Authorization of a pediatric formulation (granules in capsule for opening) of Mimpara (cinacalcet) 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.
“Secondary HPT is a serious and complex condition, and there are currently limited treatment options available for pediatric patients living with this disease,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We are pleased with today’s approval and the opportunity to provide patients and health care providers with an important therapy.”
The EC approved Mimpara based on studies Amgen began in 2007 to assess the use of Mimpara in pediatric patients with secondary HPT, who have very few treatment options, according to Amgen.
Approval from the EC grants a centralized marketing authorization with unified labeling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.