BRIEF—Chugai's Mircera injection syringe 12.5μg approved in Japan

Japanese drug major Chugai Pharmaceutical says it has obtained approval from the Ministry of Health, Labor and Welfare for Mircera (epoetin beta pegol) injection syringe 12.5μg, the lowest content preparation of the long-acting erythropoiesis stimulating agent indicated for renal anemia.

Developed by Chugai’s majority owner Roche, 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 USA.

Mircera 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.