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Kyowa Kirin Receives Approval for ORKEDIA® Tablets in Japan

Thursday, August 31, 2023

Kyowa Kirin announced the approval for ORKEDIA® tablets 4mg in Japan. ORKEDIA® tablets is an oral calcimimetic agent that targets parathyroid hormone (PTH) secretion by interacting with calcium receptors on parathyroid gland cells.

The drug is approved in Japan for the treatment of various conditions, such as secondary hyperparathyroidism in patients undergoing maintenance dialysis, hypercalcemia in patients with parathyroid carcinoma, and hypercalcemia in patients with primary hyperparathyroidism who cannot undergo parathyroidectomy or who experience recurrent primary hyperparathyroidism.

In March 2018, ORKEDIA® received approval in Japan as a treatment for secondary hyperparathyroidism in patients undergoing dialysis. Subsequently, in December 2019, it received additional approval for addressing hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or experience relapse after parathyroidectomy.

The availability of different dosage strengths, including ORKEDIA® tablets 1mg and 2mg, has already proven beneficial for patients in Japan. This higher dosage of ORKEDIA® tablets 4mg is expected to have a positive impact on patient treatment by potentially reducing the burden of medication and enhancing treatment satisfaction.

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