Kyowa Kirin Announces the approval of Duvroq in Japan by GSK for Patients with Renal Anemia due to Chronic Kidney Disease

Tokyo, Japan, June 29, 2020 – Kyowa Kirin Co., Ltd. (Kyowa Kirin, TYO: 4151) today announced that GSK, its strategic collaboration partner of Duvroq (daprodustat), has announced the approval of a Japanese New Drug Application (JNDA) by the Ministry of Health, Labour and Welfare for Duvroq, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with renal anemia due to chronic kidney disease (CKD).

"The approval of Duvroq is an important milestone in providing a new treatment option for patients suffering from renal anemia and healthcare professionals.” said Tomohiro Sudo, Executive Officer, Director of Strategy Product Planning Department of Kyowa Kirin. “Kyowa Kirin continues to commit helping patients and developing new treatments for their better lives."

Further information can be found in the press release issued by GSK on 29 June 2020.

Duvroq has been developed to provide an orally-convenient treatment option which avoids the administration challenges and cold storage requirements of injectable erythropoiesis-stimulating agents /recombinant human erythropoietin (rhEPO). In addition to this, since Duvroq can be used for the patients on and not on dialysis, we expect to provide a convenient therapy to the many patients with renal anemia.

Kyowa Kirin will be exclusively responsible for the product distribution in Japan, following the strategic commercialization deal with GSK in Japan in 2018. Commercial promotional launch activities will be led by Kyowa Kirin. GSK will support Kyowa Kirin with scientific engagement through medical science liaisons.

The Kyowa 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.

Anemia is the term used to describe a decrease of red blood cells or hemoglobin concentration which carry oxygen to the body, and in general, hemoglobin is used for diagnosis of anemia. Kidneys produce hormones including erythropoietin, which stimulates red blood cell production. Renal anemia commonly arises in patients with kidney impairment because the kidneys no longer produce sufficient amount of erythropoietin, a hormone involved in prompting the production of red blood cells.¹ The incidence of renal anemia increases as kidney function declines. It is estimated that 10.9 million patients in Japan have stages 3-5 CKD and of these, 32% have anaemia.^2,3

Kyowa Kirin Co., Ltd. is a research-based life sciences company, with special strengths in biotechnologies. In the core therapeutic areas of oncology, nephrology and immunology/allergy, Kyowa Kirin leverages leading-edge biotechnologies centered on antibody technologies, to continually discover innovative new drugs and to develop and market those drugs world-wide. In this way, the company is working to realize its vision of becoming a Japan-based global specialty pharmaceutical company that contributes to the health and wellbeing of people around the world.

You can learn more about the business at www.kyowakirin.com