Kyowa Kirin has secured approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Orkedia Tablets 4mg, the generic name of which is evocalcet.
A small molecular compound and a novel type of calcimimetics discovered by Mitsubishi Tanabe Pharma Corporation, Orkedia Tablets suppresses parathyroid hormone (PTH) secretion as it acts on the calcium receptors on parathyroid gland cells.
This calcimimetics agent is approved in the country to treat secondary hyperparathyroidism in patients undergoing maintenance dialysis, hypercalcemia in patients with parathyroid carcinoma, and hypercalcemia in patients suffering with primary hyperparathyroidism and are unable to undergo parathyroidectomy or who experience recurrent primary hyperparathyroidism.
Since the launch in May 2018, its low dosage forms, Orkedia Tablets 1mg and Orkedia Tablets 2mg have helped many patients in the country, stated the company.
The higher dose form, Orkedia Tablets 4mg is expected to reduce the burden of medication for patients and lead to an improvement in the satisfaction of treatment.
In March 2008, Kyowa Kirin signed a license agreement for Orkedia with Mitsubishi Tanabe Pharma for the rights for cooperative research, development, marketing and manufacturing of the drug in Japan and some parts of Asia.
In March 2018, Orkedia was granted approval in Japan to treat secondary hyperparathyroidism in dialysis patients and was later launched in the country in May 2018.
Orkedia secured additional approval in December 2019 for treating hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.