Data from Pharmawand - Curated by EPG Health - Date added 10 November 2019

FibroGen, Inc. announced results from the Phase III HIMALAYAS trial evaluating roxadustat for the treatment of anemia in incident dialysis (ID) patients with chronic kidney disease (CKD), a clinically important subgroup of dialysis-dependent CKD patients. Incident dialysis was defined as those who initiated dialysis within 4 months before randomization to roxadustat or epoetin alfa.

In this trial of 1,043 patients, believed to be the largest trial to date investigating an anemia medicine in the ID population, roxadustat achieved both primary efficacy endpoints. The safety profile of roxadustat observed in the HIMALAYAS trial was consistent with results observed in previous roxadustat studies. This incident dialysis subpopulation is appropriate for comparison of roxadustat versus epoetin alfa, as patients experience high rates of morbidity and mortality during the period of initial dialysis treatment, whereas the stable dialysis population consists of patients who have survived this period and are already shown to be responsive to stable ESA doses.

“Roxadustat is the first of a new class of medication, applying the groundbreaking science on oxygen sensing and adaptation to hypoxia recently awarded the 2019 Nobel Prize in Physiology or Medicine,” said Robert Provenzano, MD, Associate Professor of Medicine, Wayne State University, Detroit, Michigan, U.S. and lead investigator of the HIMALAYAS study. “The positive HIMALAYAS results highlight the potential of roxadustat as an attractive new treatment option for anemia in these highly vulnerable patients who are new to dialysis care. This study provides useful insights and clinically relevant data for consideration in clinical practice, as most patients start anemia treatment when they begin dialysis.”

HIMALAYAS is an open label, active controlled, global Phase III study in which 1,043 incident dialysis patients were randomized 1:1 to receive roxadustat or epoetin alfa for up to 4.4 years, with mean treatment duration of 1.8 years. The U.S. primary efficacy endpoint of mean change in hemoglobin (Hb) levels from baseline to the average over 28-52 weeks was met as roxadustat was shown to be non-inferior to epoetin alfa, followed by demonstration of superiority (p=0.0005). The mean Hb increased from 8.4 g/dL to 11.0 g/dL in roxadustat-treated patients vs. 8.4 g/dL to 10.8 g/dL in epoetin alfa-treated patients. Roxadustat was non-inferior to epoetin alfa in the EU primary efficacy endpoint of proportion of patients achieving a Hb response (defined as Hb greater than 11.0 g/dL and Hb increased by greater than 1 g/dL from baseline) during the first 24 weeks of treatment: 88.2% in the roxadustat arm vs. 84.4% in the epoetin alfa arm. Further, patients treated with roxadustat required lower average monthly intravenous iron use than those treated with epoetin alfa (p=0.00028). The most frequently observed adverse events (AEs) with roxadustat in the HIMALAYAS trial were hypertension, diarrhea, and muscle spasms.


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