Secondary data show improvement in gMG patients treated with Soliris

US drugmaker Alexion Pharmaceuticals (Nasdaq: ALXN) has presented new secondary efficacy endpoint data on Soliris (eculizumab) in the treatment for refractory generalized myasthenia gravis (gMG) showing patient improvement at week 26.

Last month, Alexion reported that its Phase III REGAIN study of the drug failed to meet its primary endpoint, but the latest results showed that 18 of 22 pre-defined endpoints and pre-specified analyses in the study achieved p-values <0.05. The new data were presented at the Hot Topics session of the 14th International Congress on Neuromuscular Diseases (ICNMD) in Toronto.

New secondary efficacy endpoint data presented included change from baseline in Myasthenia Gravis Composite (MGC) score at week 26, which achieved a p-value of 0.1026, and change from baseline in the 15-item Myasthenia Gravis Quality Of Life (MG-QOL15) at week 26, which achieved a p-value of 0.0281, both measured by a worst-rank analysis. A pre-specified sensitivity analysis of the MGC and MG-QOL15 endpoints using repeated measures from baseline to week 26 achieved p-values of 0.0134 and 0.0010, respectively.