Genentech says satralizumab 'significantly' reduced relapse risk in second study
Genentech, a member of the Roche Group, presented full pivotal Phase III study results for satralizumab as a monotherapy for neuromyelitis optica spectrum disorder, or NMOSD, a rare, debilitating central nervous system disease. Results from the SAkuraStar study, presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, or ECTRIMS, show that satralizumab monotherapy achieved a 55% reduction in the risk of relapses compared to placebo in the overall population, representative of NMOSD patients. In the large subgroup of patients seropositive for AQP4-IgG antibodies, the effect was higher with a 74% reduction in risk of relapses. People who are AQP4-IgG seropositive tend to experience a more severe disease course. "The positive Phase III results for satralizumab, first as an add-on therapy and now as a monotherapy, are exciting to see, and importantly, satralizumab achieved efficacy in a broad range of NMOSD patients, reflective of what we see in our everyday practice. Satralizumab targets the IL-6 receptor, potentially offering a novel treatment approach," said Professor Jeffrey Bennett, University of Colorado Neurology & Ophthalmology. "Approved treatment options demonstrating favorable safety and efficacy in controlled clinical trials are urgently needed. Even one relapse may lead to blindness and debilitating motor dysfunction for people with NMOSD."