Amgen’s Mimpara for secondary HPT children with ESRD receives marketing approval in EU
US-based biopharmaceutical company Amgen has been granted marketing authorisation by the European Commission (EC) for Mimpara (cinacalcet) to treat secondary hyperparathyroidism (HPT) in children with end-stage renal disease (ESRD).
Secondary HPT is a chronic and severe condition that affects many of the people receiving dialysis.
The condition refers to the excessive secretion of parathyroid hormone (PTH) by the parathyroid glands due to decreased renal function and impaired mineral metabolism.
Amgen received marketing rights for the paediatric formulation (granules in capsule for opening) of Mimpara, the first oral calcimimetic agent approved by the EC, to treat secondary HPT in children aged three and older with ESRD on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard-of-care therapy.
Amgen research and development executive vice-president Dr Sean E. Harper said: “Secondary HPT is a serious and complex condition, and there are currently limited treatment options available for paediatric patients living with this disease.
“We are pleased with today's approval and the opportunity to provide patients and healthcare providers with an important therapy.”
The EC approval is based on the results of the studies conducted by the company as of 2007.
The studies were carried out to evaluate the use of the Amgen treatment in paediatric patients with secondary HPT who have limited treatment options.
With the approval, the company has received a centralised marketing authority in the 28 member countries of the European Union (EU).