Swiss drugmaker Vifor Pharma (VTX: VIFN) has clarified what it calls a ‘programming error’ in the original analysis by the investigators in the PIVOTAL trial.
The re-analysis of the data has revealed a statistically-significant improvement in the treatment effects of a higher dose of Venofer (intravenous iron sucrose) compared with a lower dose of the drug, which is the leading intravenous iron brand, in terms of volume usage, worldwide.
These results in hemodialysis patients, showing a significant reduction in the risk of death or major cardiovascular events with the higher dose, supersede those presented in October.
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