Ono Pharma files for approval of etelcalcetide in Japan

Japanese drugmaker Ono Pharmaceuticals (TYO: 4528) has filed a manufacturing and marketing approval application in Japan for etelcalcetide hydrochloride (ONO-5163), a calcimimetic agent, to seek an indication for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis.

Secondary hyperparathyroidism, one of complications of chronic renal failure, is a pathological condition where excessive parathyroid hormone (PTH) is secreted by parathyroid gland. Excessive PTH secretion promotes phosphorus and calcium efflux from bone which may cause symptoms including bone and joint pain. Furthermore, it is reported that vascular calcification due to accumulation of phosphorus and calcium from bone in vessels aggravates risk of cardiovascular events which adversely affects life prognosis.

In Japan, Ono entered into an exclusive license agreement with former KAI Pharmaceuticals (now a subsidiary of Amgen [Nasdaq: AMGM]) in September 2011 to develop and commercialize etelcalcetide hydrochloride. Amgen submitted a New Drug Application for etelcalcetide to the US Food and Drug Administration for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis in August 2015, and this was accepted for review by the FDA later that year (The Pharma Letter November 7, 2015), with a decision expected in August this year, and submitted a Marketing Authorization Application in Europe last September.