Astellas and FibroGen Announce Japanese Approval of Evrenzo (Roxadustat) for CKD Anemia in Dialysis Patients; China Expands Indication in August

September 23, 2019/BioonBIOON/--Japanese pharmaceutical company Astellas and its partner FibroGen recently jointly announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Evrenzo (Chinese brand name: Airuozhuo®, generic name: roxadustat), for the treatment of chronic kidney disease (CKD)-relatedAnemia。

This approval also marks the first regulatory approval for Astellas and FibroGen in their collaboration on roxadustat. The approval is based on four Phase III clinical studies evaluating roxadustat for the treatment of anemia associated with chronic kidney disease (CKD) in dialysis patients in Japan. These studies confirmed that roxadustat effectively increases hemoglobin levels and is well tolerated.

Anemia in chronic kidney disease (CKD) significantly worsens the prognosis of renal disease, accelerates progression to kidney failure, and increases the risk of cardiovascular complications, while also markedly reducing patients’ quality of life and cognitive function. Achieving and maintaining target hemoglobin levels can be challenging, and roxadustat offers an important alternative therapeutic option.

K. Peony Yu, Chief Medical Officer of FibroGen, stated, “We thank our partner, Astellas, as our joint efforts have brought a new treatment option for patients with CKD anemia undergoing dialysis in Japan. With this approval in Japan, the approval in China, and the ongoing preparation of NDAs in the European Union and the United States, we are one step closer to addressing the significant unmet medical needs of patients with CKD anemia worldwide.”

Renal anemia is one of the major complications during the decompensated stage of renal function in chronic kidney disease (CKD). As CKD progresses, the prevalence and severity of CKD-associated anemia gradually increase. Renal anemia is more difficult to correct than conventional anemia, leading to severe fatigue and reduced quality of life in patients. Currently, the standard treatment for renal anemia involves erythropoietin (EPO) replacement therapy using erythropoiesis-stimulating agents (ESAs), such as epoetin alfa, combined with intravenous iron supplementation via subcutaneous injection. This approach can effectively increase hemoglobin (Hb) levels in CKD patients and improve clinical symptoms.

Roxadustat is the first small-molecule hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) developed globally for the treatment of renal anemia. The physiological role of hypoxia-inducible factor (HIF) not only increases erythropoietin expression but also upregulates the expression of erythropoietin receptors and proteins that promote iron absorption and circulation. Roxadustat inhibits prolyl hydroxylase (PH) by mimicking one of its substrates, alpha-ketoglutarate, thereby affecting the role of PH in maintaining the balance between HIF synthesis and degradation rates, ultimately achieving the correction of anemia.

As the world’s first HIF-PHI, roxadustat promotes the production of endogenous erythropoietin, improves iron absorption and utilization, and reduces hepcidin levels. It is not subject to the negative effects of inflammation on hemoglobin and erythropoiesis, thereby effectively stimulating red blood cell production. Roxadustat has been proven to induce erythropoiesis. In multiple subpopulations of patients with chronic kidney disease, roxadustat maintains erythropoietin levels at or near the normal physiological range, thereby increasing red blood cell counts. This effect is unaffected by inflammatory status and also avoids the need for intravenous iron supplementation.

Roxadustat was discovered by FibroGen and developed in collaboration with the Japanese pharmaceutical company Astellas for the treatment of CKD-related anemia in both dialysis-dependent and non-dialysis-dependent patients. Furthermore, FibroGen has alsoAstraZenecaCollaboration to develop roxadustat in the United States, China, and other markets.

In December 2018, roxadustat (brand name: Evrenzo®) was first approved in China for the treatment of anemia in patients with chronic kidney disease (CKD) on dialysis. In August 2019, the drug received approval in China for a new indication: the treatment of anemia in non-dialysis-dependent chronic kidney disease (NDD-CKD) patients. As a global first-in-class novel drug, roxadustat has pioneered comprehensive application in China for both dialysis-dependent and non-dialysis-dependent CKD patients with anemia, bringing a groundbreaking therapeutic advance to the broad population of Chinese CKD patients. AstraZeneca and FibroGen (China) are expected to launch roxadustat in the Chinese market in the second half of this year. (Bioon.com)

Original Source:Evrenzo? (roxadustat) Tablets Approved in Japan for the Treatment of Anemia Associated with Chronic Kidney Disease in Dialysis Patients