Astellas new drug roxadustat 3 placebo-controlled trial ALPS reaches major endpoint

CKD (also known as chronic renal insufficiency or chronic renal failure) is a disease in which renal function occurs with intractable decline over a period of months or yearsrecently, Astellas Pharma announced that itsnew drug(ASP1517 / FG-4592) for patients with anaemic chronic kidney disease (CKD) reached its main endpoint in three placebo-controlledtrial
s worldwideresults showed that roxadustat showed a far better effect than placeboPreliminary safetyanalysis(results show that the overall safety of roxadustat is consistent with previous testresults for anaemic CKDAbout Roxadustat
Roxadustat is a mixed oral small molecule hypoxic inducing factor (HIF) protaphylocopic hydroxylase inhibitor for patients with dialysis and non-dialysis anemia CKD, discovered and developed by Astellas partner FibroGenHIF is a protein transcription factor that induces natural physiological reactions to low oxygen conditions and opens up red blood cell production and other protective pathwaysthe ALPS test, whichthe results, was the first of three phase 3 trials conducted by the Astellas EMEA (Europe, Middle East and Africa) Centre to report the resultsThe worldwide large-scale Phase 3 trial was carried out by Astellas in conjunction with FibroGenthe study is a multicenter randomized double-blind placebo-controlled trial of 52-104 weeks to assess the efficacy and safety of roxadustat for patients with non-dialysis anemia CKD The trial was conducted in patients with non-dialysis anemia CKD (average Hb s 10 g/dL), of which two thirds were randomly assigned to the roxadustat group and the other third were randomly assigned to the placebo group the trial had two main endpoints, including the Hb response rate for the first 24 weeks (including only U.S patients) and the average number of Hb than baseline changes in 28-52 weeks (only in Patients in Europe and the Middle East) results showed that roxadustat reached its main endpoint and had good tolerance and safety