FDA accepts BLA for satralizumab for neuromyelitis optica spectrum disorder- Genentech/Roche

Genentech, a member of the Roche Group, announced that the FDA has accepted the company�s Biologics License Application (BLA) for satralizumab for the treatment of adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD). The European Medicines Agency (EMA) has also validated the company�s Marketing Authorization Application (MAA) for satralizumab, granting it Accelerated Assessment. The FDA decision and the EMA�s Committee for Medicinal Products for Human Use (CHMP) recommendation are expected in 2020.

The satralizumab applications are based on positive results from two Phase III studies, SAkuraStar and SAkuraSky, evaluating the efficacy and safety of satralizumab as a monotherapy and in combination with baseline immunosuppressant therapy, respectively. In the SAkuraStar study, satralizumab monotherapy achieved a 55% reduction in the risk of relapses compared to placebo in the overall study population of aquaporin-4 antibody (AQP4-IgG) seropositive and seronegative patients (Hazard Ratio [HR]=0.45, 95% Confidence Interval [CI]: 0.23-0.89; p=0.0184). Satralizumab achieved a 74% reduction (HR=0.26, 95% CI: 0.11-0.63; p=0.0014) in the larger (~67%) subgroup of AQP4-IgG seropositive patients, who tend to experience a more severe disease course. In the overall satralizumab-treated population, 76.1% were relapse-free at 48 weeks, and 72.1% relapse-free at 96 weeks, compared to 61.9% and 51.2% with placebo, respectively. Data from the AQP4-IgG seropositive subgroup showed that 82.9% were relapse-free at 48 weeks and 76.5% relapse-free at 96 weeks when treated with satralizumab, compared to 55.4% and 41.1% with placebo, respectively.

Additionally, the SAkuraSky study data showed a 62% reduction in the risk of relapses compared to placebo in the overall study population (HR=0.38, 95% CI: 0.16-0.88; p=0.0184) when used in combination with baseline immunosuppressant therapy, and a 79% reduction in the risk of relapses in AQP4-IgG seropositive patients (HR=0.21, 95% CI: 0.06-0.75; p=0.0086). In the overall satralizumab-treated population, 88.9% were relapse-free at 48 weeks, and 77.6% were relapse-free at 96 weeks, compared to 66.0% and 58.7% with placebo, respectively. Data from the AQP4-IgG seropositive subgroup showed that 91.5% were relapse-free at 48 and 96 weeks when treated with satralizumab, compared to 59.9% and 53.3% with placebo, respectively..

Overall, the proportion of patients with serious adverse events was similar between the satralizumab and placebo treatment groups in both studies..