Amgen has 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.
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.
Secondary hyperparathyroidism (HPT) is a chronic and serious condition which affects many of the approximately two million people throughout the world who are receiving dialysis. It occurs in both adults and children. Approximately 88 percent of chronic kidney disease (CKD) patients on hemodialysis will develop secondary HPT. Secondary HPT refers to the excessive secretion of parathyroid hormone (PTH) by the parathyroid glands in response to decreased renal function and impaired mineral metabolism. The elevated levels of PTH can lead to an increase in the release of calcium and phosphate from the bone. Secondary HPT is often initially silent and asymptomatic. As a result, secondary HPT is frequently underdiagnosed and undertreated.
Mimpara (cinacalcet) was originally approved in the EU in 2004 and is the first oral calcimimetic agent approved by the EC for the treatment of secondary HPT in patients with ESRD on maintenance dialysis therapy. The therapy is also approved in the EU for the reduction of hypercalcemia in adult patients with parathyroid carcinoma and with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated. Mimpara binds to the calcium-sensing receptor, resulting in a drop in PTH levels by inhibiting PTH synthesis and secretion. In addition, the reductions in PTH lower serum calcium and phosphorus levels.
Sensipar is the first oral calcimimetic agent approved by the FDA for the treatment of secondary HPT in adult patients with CKD on dialysis. Sensipar is not indicated for use in adult patients with CKD who are not on dialysis because of an increased risk of hypocalcemia. The therapy is also approved in the U.S. for treatment of hypercalcemia in adult patients with parathyroid carcinoma and hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. Sensipar binds to the calcium-sensing receptor, resulting in a drop in parathyroid hormone (PTH) levels by inhibiting PTH synthesis and secretion. The reduction in PTH is associated with a concomitant decrease in serum calcium levels. Sensipar is not indicated for use in pediatric patients (patients less than 18 years of age).