September 20, 2013
Approval of Long-Acting Erythropoiesis-Stimulating Agent NESP® Injection 5μg Plastic Syringe in Japan
Tokyo, Japan, September 20, 2013 -- Kyowa Hakko Kirin Co., Ltd. (President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that NESP® Injection 5μg Plastic Syringe has been approved for manufacturing and marketing in Japan as an additional formulation in Japan.
NESP®, a long-acting erythropoiesis stimulating agent, was initially approved in July 2007. NESP® is highly recognized for its safety and efficacy for treating anemia of adult chronic kidney disease patients on / not on dialysis and is widely used in various medical institutions.
The additional indication of pediatric renal anemia was approved on September 13, 2013 in Japan, allowing NESP® to be used in renal anemia in both pediatric and adult patients with chronic kidney disease.
The approval of NESP® Injection 5μg Plastic Syringe enables expansion of NESP line-up. With the approval, we believe and hope to contribute to various needs of the patients suffering from anemia of chronic kidney disease.
Kyowa Hakko Kirin is focusing on kidney area, along with three other focused areas as our category-based strategy*. With a variety kinds of products, Kyowa Hakko Kirin will contribute for kidney diseases.
* Category-based strategy: Each category (Nephrology; Oncology; Immunology and allergy; and Central Nervous System) will have its own portfolio management from R&D through to sales. We will achieve sustained growth while striving to improve productivity.
Kyowa Hakko Kirin