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    Home > Active Ingredient News > Drugs Articles > Target the Nobel Prize signal channel! Rosastah is expected to get FDA approval this year

    Target the Nobel Prize signal channel! Rosastah is expected to get FDA approval this year

    • Last Update: 2020-02-16
    • Source: Internet
    • Author: User
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    Recently, fibrogen announced that the FDA of the United States has accepted the new drug application (NDA) of "first in class" hypoxia inducible factor proline hydroxylase inhibitor (hif-phi) roxadustat jointly developed by the company with AstraZeneca to treat anemia caused by chronic kidney disease Type 2 patients FDA is expected to respond on December 20 this year Anstela said it expects to submit roxadustat's marketing authorization application to the European Drug Administration in the first half of this year Renal anemia is one of the main complications of renal decompensation in chronic kidney disease (CKD) According to press release statistics, the prevalence of CKD is between 10% and 12% of the global adult population With the development of CKD, the prevalence and severity of CKD related anemia are increasing Patients with renal anemia often feel weak and have poor quality of life At present, the standard treatment of renal anemia is erythropoiesis stimulant (ESA) such as afaibutin and intravenous iron Roxadustat is an oral small molecule hypoxia inducible factor prolyl hydroxylase inhibitor (hif-phi) for the treatment of renal anemia The physiological function of hypoxia inducible factor (HIF) can not only increase the expression of erythropoietin, but also increase the expression of erythropoietin receptor and the protein promoting iron absorption and circulation Roxadustat inhibits pH enzyme by simulating ketoglutarate, one of the substrates of proline hydroxylase (PH), and affects the role of pH enzyme in maintaining the balance of HIF production and degradation rate, so as to correct anemia Roxadustat has been approved for marketing in China to treat patients with anemia caused by chronic kidney disease It is worth mentioning that the target "oxygen sensing pathway" of the drug just won the Nobel Prize in October last year ▲ molecular structure formula of losartan (photo source: meodipt [public domain or public domain], from Wikimedia Commons) the submission of the new drug application is based on the positive results of the three-phase clinical development project including 15 clinical trials, which has recruited more than 10000 patients worldwide Earlier, the New England Journal of Medicine (NEJM) published the positive results of roxadustat in two phase 3 clinical trials The results showed that there was no significant difference in clinical benefits and side effects between roxadustat and standard therapy Roxadustat can effectively correct and maintain the hemoglobin level of patients with renal anemia In addition, fabergin has previously published positive results of roxadustat in five other phase 3 trials These data indicate that roxadustat can provide clinical benefits for dialysis dependent and non dependent CDK patients compared with current standard therapies "There is a large unmet need for the treatment of CKD anemia However, in the past 30 years, the treatment progress of the disease has been very limited, "said peony Yu, MD, chief medical officer of fabergin." we look forward to working with FDA and our partners to bring roxadustat to dialysis / non dialysis patients with anemia due to chronic kidney disease as soon as possible " Reference: [1] fibrogen announcements U.S FDA acceptance of new drug application for roxadustat for the treatment of anemia of chronic kidney disease, retrieved February 12, 2020, From https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-announcements-us-fda-acceptance-new-drug-application note: This paper aims to introduce the progress of medical health research, not the recommendation of treatment scheme For guidance on treatment options, please visit a regular hospital.
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