EC approves Amgen's Mimpara for pediatric indication

In August, Amgen Inc. (NASDAQ:AMGN) said the European Commission approved an expanded label for Mimpara cinacalcet (KRN1493, AMG 073) to treat secondary hyperparathyroidism not adequately controlled with standard therapy in patients ages ≥3 with end-stage renal disease (ESRD) on maintenance dialysis. The second-generation calcimimetic is already approved for the indication in adults, and is also approved to reduce hypercalcemia in adults with parathyroid carcinoma and primary hyperparathyroidism.

Amgen markets the product as Sensipar in the U.S. and Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) markets it as Regpara in Japan...