Long-Acting Erythropoiesis Stimulating Agent “MIRCERA Injection Syringe 12.5μg” Approved in Japan

TOKYO, March 20, 2018 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it obtained approval from the Ministry of Health, Labour and Welfare yesterday for “MIRCERA® Injection Syringe 12.5μg,” the lowest content preparation of the long-acting erythropoiesis stimulating agent “MIRCERA” (generic name: epoetin beta pegol) sold for the indication of "renal anemia."

Developed by Roche, MIRCERA is a long-acting erythropoiesis stimulating agent that raises the stability of epoetin beta in the bloodstream through pegylation. It stimulates erythropoiesis by a different interaction with the erythropoietin receptor on progenitor cells in the bone marrow, and enables stable and sustained control of anemia. MIRCERA was launched in Japan in July 2011 as a treatment for renal anemia. Outside Japan, MIRCERA is sold in more than 100 countries including the United States.

MIRCERA, used for the treatment of patients with renal anemia, is currently available from Chugai in seven dosage strengths: 25μg, 50μg, 75μg, 100μg, 150μg, 200μg, and 250μg. However, healthcare providers urged Chugai to add an even lower content preparation of MIRCERA in order to increase the flexibility of adjusting dosage. Considering the significant need for a lower content preparation to improve the treatment and quality of life of patients, Chugai started developing the 12.5μg preparation and filed an application for approval.

Chugai is convinced that “MIRCERA Injection Syringe 12.5μg” will contribute to the improvement of patients' satisfaction with treatment. The Company will continue striving to improve medical care for renal anemia and address unmet medical need based on our business philosophy of “Innovation all for the patients.”

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