Astellas Pharma (OTCPK:ALPMF) announces positive results from a Phase 3 clinical trial, DOLOMITES,
evaluating roxadustat for the treatment of anemia in
non-dialysis-dependent adults with stage 3-5 chronic kidney disease. The
data were virtually presented at the European Renal
Association-European Dialysis and Transplant Association Congress.
The study demonstrated the non-inferiority (no worse than) of roxadustat to Amgen’s (NASDAQ:AMGN)
Aranesp (darbepoetin alfa) as measured by hemoglobin response up to
week 24. Specifically, the change in hemoglobin in the roxadustat cohort
was 89.5%, compared to 78.0% in the darbepoetin alfa cohort.
Roxadustat demonstrated superiority over
darbepoetin alfa in reducing low-density lipoprotein cholesterol (“bad”
cholesterol), a secondary endpoint.
The safety profiles were similar.
The company’s marketing application in Europe is under EMA review.
Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF)
prolyl hydroxylase. HIF is a protein transcription factor that “turns
on” the production of red blood cells (erythropoiesis). Its value
proposition is the ability to maintain hemoglobin levels without
affecting inflammation and potentially avoiding the need for ongoing
intravenous iron repletion therapy as needed with bone marrow
stimulating agents like Aranesp and Johnson & Johnson’s (NYSE:JNJ) Procrit (epoetin alfa).
https://seekingalpha.com/news/3581007-astellas-roxadustat-successful-in-late-stage-anemia-study
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