Positive results for Soliris in aHUS-Alexion Pharma

Alexion Pharmaceuticals announced new data from clinical trials of Soliris (eculizumab) in patients with atypical Hemolytic Uremic Syndrome (aHUS). New results from a 1-year update of the largest prospective trial of Soliris in adult patients with aHUS, shows that TMA inhibition and improved renal outcomes were sustained and increased numbers of patients achieved renal improvement with ongoing treatment with Soliris. In addition, there was a reported 97% reduction in risk of progression to end-stage renal disease in patients with aHUS receiving Soliris compared to patients receiving supportive care only, based on an analysis from the two Soliris registration clinical trials. Observed improvements in hematologic and renal outcomes in patients with aHUS treated with Soliris were regardless of dialysis or transplant history, based on three post-hoc sub-analyses from two prospective open-label, single-arm trials of Soliris in adult and pediatric patients. Finally, data shows markers of alternative complement pathway activation and endothelial cell activation were reduced with sustained Soliris treatment but remained elevated without clinical consequences, suggesting that patients with aHUS have ongoing dysregulation of complement and supporting the need for sustained terminal complement blockade with Soliris. Data were presented at Kidney Week 2014.