Roche's satralizumab significantly cuts relapse risk in neuromyelitis optica spectrum

Swiss pharma giant Roche (ROG: SIX) today presented full pivotal Phase III study results for satralizumab as a monotherapy for neuromyelitis optica spectrum disorder (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 (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 (HR 0.45, 95% CI: 0.23-0.89; p=0.0184). In the large (~67%) subgroup of patients seropositive for AQP4-IgG antibodies, the effect was higher with a 74% reduction in risk of relapses (HR 0.26, 95% CI: 0.11-0.63; p=0.0014). People who are AQP4-IgG seropositive tend to experience a more severe disease course.

The drug, which gained Breakthrough Therapy designation from the US Food and Drug Administration last December, was developed by Japan’s Chugai Pharmaceutical (TYO: 4519), which is majority owned by Roche. The positive results are likely to mean that Roche will soon plan regulatory filings.

Would compete with Alexion’s Soliris