Chugai Pharmaceutical Co, Ltd announced that the company filed a new drug application (NDA) for R744, a long-acting erythropoiesis-stimulating agent, for the treatment of anaemia associated with chronic kidney disease (renal anaemia) with the Japanese Ministry of Health, Labour and Welfare (MHLW).
Renal anaemia is one of the most frequent complications with chronic kidney disease (CKD), with significant impact on patients' quality of life. R744 is a continuous erythropoietin receptor activator which has a different interaction on the receptor level compared to other erythropoiesis stimulating agents. It was launched outside Japan in 2007 under the product name Mircera as an innovative anti-anaemia medication that allows a once-monthly maintenance therapy. With its extended dosing frequency compared to existing therapies, the product is contributing to the advancement of the management of renal anaemia overseas.
Chugai conducted clinical trials for R744 in renal anaemia patients in Japan. The results of these studies confirmed its efficacy and tolerability in CKD patients with once-every-four-week intravenous or subcutaneous dosing in maintenance therapy, which led to the filing today.
In recent years, there has been a significant increase in CKD patients with underlying diabetes. The increasing prevalence of CKD raises awareness of the importance of earlier treatment of anaemia and simplified anaemia management in these patients. To support treatment, guidelines have been issued by the Japanese Society for Dialysis Therapy and the Japanese Society of Nephrology in 2008 and 2009, respectively.
The area of renal diseases is one of the strategic focus areas for Chugai. Chugai will continue to focus on obtaining marketing authorization for R744 to make this new treatment option available for anaemic patients with CKD and medical professionals in addition to the currently available standard therapy, the recombinant human erythropoietin EpoginR.
R744 is a long-acting erythropoiesis stimulating agent (ESA) which has the longest serum half-life among ESAs on the market.