FDA accepts biota license application for gene tekil-6 antibody satralizumab

Today, Roche's Genentech announced that the U.SFDA(http://has accepted its IL-6 antibody satralizumab biologic license application (BLA) for the treatment of adult synods and adolescent patients with psynocoeur cord inflammation disorder (NMOSD)At the same time, the EuropeanMedicines(http://Authority (EMA) has accepted satralizumab's marketing authorization application (MAA) and granted it the Accelerated AssessmentThe application is based on positive results from two key Phase 3 clinical studies called SakuraStar and Sakura SkyThe twotrials(http://assessed the efficacy and safety of satralizumab as a monotherapy, and in combination with standard therapy for NMOSD patientsSakuraStar's study showed that patients treated with satralizumab alone had a 55 percent lower risk of relapse than the placebo groupThe non-recurrence rates at 96 and 48 weeks were 76.1% and 72.1%, respectively, compared with 61.9% and 51.2% in placebo groupsIn subgroups of patients carrying AQP4 autoantibodies, the risk of recurrence was reduced by 74% in patients treated with satralizumab monotherapyThe non-recurrence rates at 96 and 48 weeks were 76.5% and 82.9%, respectively, compared with 41.1% and 55.4% in placebo group patientsSakuraSky's findings showed that patients who received satralizumab in combination with standard therapy had a 62 percent lower risk of relapse than the placebo groupThe non-recurrence rates at 96 and 48 weeks were 77.6% and 88.9%, respectively, compared with 58.7% and 66% in placebo groupsIn subgroups carrying AQP4 autoantibodies, patients receiving satralizumab combined with standard therapy had a 79 percent lower risk of relapseThe rate of non-recurrence at 96 and 48 weeks was 91.5%, compared with 53.3% and 59.9% in the placebo group, respectively