Roxadustat (Evrenzo®) Approved in China for Anemia Treatment in Non-Dialysis-Dependent CKD Patients, Expanding Global First-in-Class Indication

August 23, 2019 /Bio ValleyBIOON/ --AstraZenecaIt was recently announced that its partner, FibroGen China, has obtained approval from the National Medical Products Administration (NMPA) of China for a new indication: roxadustat (brand name: Evrenzo®) is indicated for non-dialysis-dependent chronic kidney disease (NDD-CKD).AnemiaTreatment. It is worth noting that this marks the first expansion of the indications for roxadustat since its approval on December 17, 2018, for the treatment of anemia in patients with chronic kidney disease (CKD) undergoing dialysis. As a global first-in-class innovative drug, roxadustat has pioneered comprehensive application in China for both dialysis-dependent and non-dialysis-dependent CKD patients with anemia, bringing a novel therapeutic breakthrough to the vast population of Chinese patients with chronic kidney disease. AstraZeneca and FibroGen China are expected to launch roxadustat in the Chinese market in the second half of this year.

Roxadustat is the world’s first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), jointly developed by AstraZeneca and FibroGen. As the first Class 1 new drug to undergo simultaneous global development with its initial launch in China, Roxadustat was included in China’s National Science and Technology Major Project for “Major New Drug Innovation.” Benefiting from strong government support for pharmaceutical innovation and deepened reforms in drug review and approval, Roxadustat received priority review from the China National Medical Products Administration and was scheduled for full market launch in China in the second half of 2019.

The approval of the new indication for roxadustat was based on a randomized, double-blind, placebo-controlled Phase III clinical trial (Study 808) conducted in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) in China. The results demonstrated that treatment with roxadustat led to a statistically significant improvement in hemoglobin levels from baseline during weeks 7 to 9, with a mean change of 1.9 g/dL, compared to -0.4 g/dL in the placebo group. These data were published in The New England Journal of Medicine (NEJM) in July 2019.

Mene Pangalos, Executive Vice President of Global R&D and Head of BioPharmaceuticals R&D at AstraZeneca, stated, “We are delighted to bring roxadustat, a global first-in-class innovative medicine, to patients in China with anemia associated with chronic kidney disease (CKD), both on dialysis and not on dialysis. This expansion of indications marks another new milestone for roxadustat following numerous breakthroughs, and it is the result of the concerted efforts of countless healthcare professionals, patients, and pharmaceutical researchers.”

Mr. Wang Lei, Executive Vice President of AstraZeneca and President of International Business and China, stated: “AstraZeneca remains steadfastly committed to science-first principles, prioritizing innovation and focusing on the unmet medical and healthcare needs of patients in China. With strong support from China’s pharmaceutical innovation policies, the rapid approval of new indications for roxadustat underscores the progress of innovative drugs in China.”Clinical TrialThe advancement and maturation of the system reflect the overall upgrade of China’s pharmaceutical innovation capabilities. In the future, AstraZeneca will continue to intensify its efforts to promote local innovation and actively facilitate greater and prioritized access to innovative medicines for patients in China.

Chronic kidney disease (CKD) has become a significant public health issue in China, with a prevalence of 10.8% among Chinese adults, affecting nearly 120 million individuals. As one of the common complications of CKD, renal anemia has a prevalence of 98.2% in dialysis-dependent CKD patients and 52.1% in non-dialysis-dependent CKD patients. According to a survey conducted in Shanghai on the status of anemia in non-dialysis patients, the prevalence of anemia in CKD stages 1–5 was 22.4%, 30.0%, 51.1%, 79.2%, and 90.2%, respectively. The overall prevalence of anemia in non-dialysis patients was 51.5%, with an anemia treatment rate of 44.9%, while the treatment target attainment rate (11–12 g/dL) was only 8.2%, indicating a substantial unmet clinical need for the management of renal anemia.

Currently, the prevalence of renal anemia in China is high, yet the awareness, treatment, and target attainment rates remain low, resulting in inadequate management of anemia among patients with chronic kidney disease. Renal anemia is a significant risk factor contributing to increased hospitalization rates, cardiovascular disease, and mortality risk. It not only adversely affects patients' physical and mental health as well as their social functioning, but also imposes a substantial disease burden on their families and society at large.

Roxadustat (roxadustat) Molecular Structure

Roxadustat is the first oral novel drug approved for marketing in China for the treatment of renal anemia, receiving approval from the National Medical Products Administration (NMPA) in December 2018 for the treatment of anemia in patients with chronic kidney disease (CKD) on dialysis. Prior to its approval in China, this medication had not been marketed in any other country. As the world’s first hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), roxadustat promotes the production of endogenous erythropoietin, improves iron absorption and utilization, reduces hepcidin levels, and effectively stimulates erythropoiesis without being adversely affected by inflammation on hemoglobin and red blood cell production. Roxadustat has been confirmed 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. Its efficacy is unaffected by inflammatory status, and it can also avoid the need for intravenous iron supplementation.

AstraZeneca and FibroGen China have partnered to jointly conduct the research, development, and commercialization of roxadustat in China. Headquartered in Beijing, FibroGen China is a wholly-owned subsidiary of FibroGen, Inc., supporting the R&D and registration programs for roxadustat. FibroGen China is responsible for conducting Phase III clinical trials of roxadustat in China and submitting its New Drug Application (NDA) for market approval to the regulatory authorities. Following the approval of this new indication for roxadustat, AstraZeneca will be responsible for the commercialization of roxadustat in China, while FibroGen China will oversee drug manufacturing, medical affairs, and furtherClinical Trialsand related regulatory matters. (Bioon.com)

Original Source:AstraZeneca China