During this study, treatment with satralizumab reduced the number of NMOSD relapses by 74% in participants who were anti-AQP4 positive compared to treatment with a placebo (inactive treatment).A study of satralizumab as an adjuvant to immunosuppressant treatment for NMOSD included 76 adult participants; 52 were anti-AQP4 positive. Immunosuppressant treatment in combination with satralizumab reduced the rate of relapses in participants who were anti-AQP4 positive by four-fifths compared to immunosuppressant treatment alone.The U.S. Food and Drug Administration (FDA) approved satralizumab based on evidence from two clinical trials (Trial 1/ NCT02073279 and Trial 2/NCT02028884) of 116 participants with NMOSD who were anti-aquaporin-4 (AQP4) antibody positive. The trials were conducted at 62 sites in the United States, Canada, Europe and Asia. Participants received at random either satralizumab or placebo injections according to the schedule. Neither the participants nor the healthcare providers knew which treatment was being given. In the second trial, all participants were also receiving their current immunosuppressive medications for the treatment of NMOSD. The benefit of satralizumab was evaluated by measuring the time to the first attack and comparing it to placebo.There was no evidence of a benefit in participants who were anti-AQP4 antibody negative in either trial. Society and culture
Legal status
Satralizumab was approved for the treatment of AQP4-IgG-seropositive NMOSD in Canada, Japan, and Switzerland.Satralizumab was approved for medical use in the United States in August 2020. The U.S. Food and Drug Administration (FDA) granted the application for satralizumab fast track and orphan drug designations.
The FDA granted the approval of Enspryng to Genentech Inc. Satralizumab is the third approved treatment for NMOSD in the United States. Names
Satralizumab is the international nonproprietary name (INN) and the United States Adopted Name (USAN). References
External links
"Satralizumab". Drug Information Portal. U.S. National Library of Medicine. Clinical trial number NCT02028884 for "Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)" at ClinicalTrials.gov</ref>
Clinical trial number NCT02073279 for "Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)" at ClinicalTrials.gov