Pralia denosumab regulatory update

Daiichi Sankyo said Japan's Ministry of Health, Labor and Welfare (MHLW) approved Pralia denosumab to treat osteoporosis. The human mAb targeting receptor activator of NF-kappa B ligand ( RANKL) is approved in Japan as Ranmark to treat bone complications stemming from multiple myeloma (MM) and bone metastases from solid tumors (see BioCentury, Jan. 23, 2012). Daiichi has Japanese rights to denosumab to treat postmenopausal osteoporosis and bone-metastatic cancers from Amgen. Daiichi and AstraZeneca plc (LSE:AZN; NYSE:AZN, London, U.K.) are partnered to co-promote denosumab in Japan for bone disorders stemming from bone metastasis (see BioCentury, May 30, 2011). ...