Kyowa Hakko Kirin files for added indication for evocalcet

Japanese mid-size drugmaker Kyowa Hakko Kirin (TYO: 4151) has submitted a supplemental application on KHK7580 (evocalcet) for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy to the Ministry of Health, Labor and Welfare (MHLW) in Japan.

This application is based on the interim result (24 weeks) of the Phase III study that evaluates the efficacy of KHK7580 for hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy. The primary endpoint is the percentage of subjects whose corrected serum calcium level is maintained ≤ 10.3mg/dL for 2 weeks in the evaluation period in a time frame up to 24 weeks. The primary endpoint was met with a 77.8% result, which exceeds the threshold set in the protocol.

KHK7580 was also granted Orphan Drug designation for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy by the MHLW on March 4, 2019.