BioCentury
ARTICLE | Clinical News

EMA's CHMP recommends pediatric label expansion for Amgen's Mimpara

July 7, 2017 8:46 PM UTC

EMA’s CHMP recommended a label expansion for Mimpara cinacalcet (KRN1493, AMG 073) from Amgen Inc. (NASDAQ:AMGN) to include treatment of secondary hyperparathyroidism not adequately controlled with standard therapy in children 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...