European Commission approves pediatric use of Mimpara
The European Commission (EC) has granted marketing authorization of a pediatric formulation (granules in capsule for opening) of Mimpara (cinacalcet).
According to US biotech major Amgen (Nasdaq: AMGN), Mimpara is approved 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 Harper, executive vice president of R&D at Amgen, adding: "We are pleased with today's approval and the opportunity to provide patients and health care providers with an important therapy."
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