News Release

Kyowa Hakko Kirin Launches ORKEDIA® TABLETS (Evocalcet) for the Treatment of Secondary Hyperparathyroidism in Patients on Maintenance Dialysis in Japan

May 22, 2018

Tokyo, Japan, May 22, 2018 ---Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and COO: Masashi Miyamoto, "Kyowa Hakko Kirin") announced today that ORKEDIA® TABLETS (generic name: evocalcet, code name: KHK7580) has been listed on the National Health Insurance (NHI) Drug Price List and launched for the treatment of secondary hyperparathyroidism in patients on maintenance dialysis in Japan.

ORKEDIA® TABLETS is a new type of oral calcimimetics agent. The drug suppresses parathyroid hormone secretion by acting on the calcium receptors on parathyroid gland cells in a similar way to the approved drug REGPARA® TABLETS (cinacalcet hydrochloride). Manufacturing and marketing authorization for ORKEDIA TABLETS was granted by from Japan's Ministry of Health, Labor and Welfare (MHLW) on March 23 2018. Compared with REGPARA® TABLETS, ORKEDIA® TABLETS have demonstrated a significant reduction in incidence of the upper gastrointestinal tract disorders through its Ph3 clinical study. A reduction in the risk of co-administration was also observed in the drug interaction study.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

Product Information
Generic Name Evocalcet
Indications Secondary hyperparathyroidism in patients on maintenance dialysis.
Packaging ORKEDIA® tablet 1mg: [PTP]100 tablets (10 tablets/PTP), box
ORKEDIA® tablet 2mg: [PTP]100 tablets (10 tablets/PTP), box
Approval Date March 23, 2018
Date of NHI price listing May 22, 2018
NHI drug price 1 mg/tablet: 280.70 yen, 2 mg/tablet: 412.10 yen
About KHK7580 (evocalcet)
KHK7580 is a small molecular compound and the novel type of calcimimetics discovered by Mitsubishi Tanabe Pharma Corporation (President & Representative Director, CEO: Masayuki Mitsuka, "Mitsubishi Tanabe Pharma"). Kyowa Hakko Kirin signed a license agreement for KHK7580 with Mitsubishi Tanabe Pharma for the rights to cooperative research, develop, market and manufacture the product in Japan and some parts of Asia on March 2008.
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