Recently, there is a good news for roxadustat, which is in the midst of the controversy. On August 19, 2021 local time, Astellas Pharma Inc. and FibroGen jointly announced that roxadustat was approved by the European Commission (EC) for adult patients with symptomatic anemia of chronic kidney disease (CKD) (see Image 1 for information on official website of FibroGen).
Image 1 From official website of FibroGen
Part I: Basic knowledge of the product
As the world's first small molecule hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) to treat renal anemia, roxadustat could promote the generation of erythrocytes by increasing the production of endogenous erythropoietin, improving iron absorption and mobilization, and down-regulating hepcidin. In 2019, scientists who discovered the mechanism of hypoxia-inducible factors were awarded the Nobel Prize in Physiology or Medicine, and the birth of roxadustat based on the relevant scientific research achievements has attracted much attention. Roxadustat was independently developed by American FibroGen, while AstraZeneca is responsible for its registration and commercial promotion in China, the United States, other American markets, Australia/New Zealand and Southeast Asia. The development and commercialization in Japan, Europe, Turkey, Russia, Commonwealth of Independent States, Middle East and South Africa lies on Astellas Pharma Inc.
Part II: Registration process of roxadustat in China
AstraZeneca is responsible for the registration and commercial mutual promotion in China in accordance with the agreement between FibroGen and AstraZeneca; while FibroGen (China) Medical Technology Development Co., Ltd. is the producing medical supplies manufacturer.
In 2010, roxadustat was approved to conduct clinical research in China. In October of the same year, Phase I clinical trial was launched. From July 2011 to 2013, the Phase II multi-center clinical research of roxadustat was carried out and completed in 13 centers across the country. In August 2015, roxadustat was approved for Phase III clinical trial. In 2016, the Phase III clinical trial of roxadustat for dialysis and non-dialysis CKD anemia was officially launched in China, and it was completed in 2017. In August 2017, an application for market in China was submitted by roxadustat.
On December 17, 2018, roxadustat passed the priority review process in China, and was approved for the treatment of renal anemia in dialysis patients, becoming the first orally small molecule HIF-PHI new drug for the treatment of renal anemia. Roxadustat has also become an innovative drug that was launched in China for global orientation, which drew global attention. On August 16, 2019, roxadustat passed the priority review process and was approved for the treatment of renal anemia in non-dialysis patients.
According to the review report of roxadustat published by CDE, 41 clinical trials have been completed worldwide and more than 10,000 subjects have been enrolled in the roxadustat clinical project. The clinical trials enrolled 2,333 subjects who had been treated with roxadustat, 213 of whom had taken roxadustat for more than 1 year. It can be said that sufficient long-term data are available. In addition, the critical Phase III clinical research 808 confirmed the efficacy of roxadustat in the treatment of anemia in patients with non-dialysis chronic kidney disease.
The post-authorization requirements in the review report also show that the following studies shall be completed: 1) Post-Authorization Safety Study (PASS), 2) Detection Identification & Monitoring (DIM), and 3) Dose Optimization Study. Currently, the applicant has submitted a clinical trial protocol for a post-authorization st...
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