Tags : Neuromyelitis Optica Spectrum Disorder

Viela Bio’s Uplizna (inebilizumab-cdon) Receives the US FDA’s Approval to

Shots: The approval is based on N-MOmentum trial which involves assessing of Uplizna (300mg) vs placebo in 213 patients in the ratio (3:1) at day 1 to day 15 who are anti-AQP4 antibody-positive/negative    The study resulted in anti-AQP4 antibody-positive group remained relapse-free (89% vs 58%) including reductions in NMOSD-related hospitalizations with safety and tolerability […]Read More

Chugai Reports Results of P-III SAkuraStar Study of Satralizumab for

Shots: The P-III SAkuraStar study involves assessing of satralizumab (120mg, SC) vs PBO in 95 patients aged 20-70yrs. in a ratio (2:1) @0, 2, and 4wks. The subsequent treatment was continued at 4wks. intervals in patients with NMOSD The P-III SAkuraStar study results: 55% reduction in risk of relapse in overall population, met its 1EPs […]Read More

Roche Reports EMA and FDA’s Acceptance of Marketing Application for

Shots:  The EMA has validated MAA for Satralizumab and granted it accelerated assessment to treat adult and adolescent patients with NMSOD. The US FDA has also accepted the BLA for Satralizumab with the expected CHMP & FDA’s decision in 2020 The marketing application is based on two P-III SAkuraStar and SAkuraSky studies assessing Satralizuma as […]Read More

Roche Reports Results of Satralizumab in Second P-III Study for

Shots: The second P-III SAkuraStar study involves assessing of Satralizumab (120 mg) as monothx. vs PBO in97 patients in a ratio (2:1) with AQP4-IgG seropositive or seronegative NMO and AQP4-IgG seropositive NMOSD aged 20-70yrs. The P-III SAkuraStar study results: 55% & 74% reduction in risk of relapse in overall population & AQP4-IgG seropositive patients; relapse […]Read More

Alexion’s Soliris (eculizumab) Receives European Commission’s Approval for Neuromyelitis Optica

Shots: The EC approval is based on P-III PREVENT study assessing Soliris vs PBO in patients with NMOSD who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of therapy and an undergoing extension study (ECU-NMO-302) The P-III PREVENT study results: met its 1EPs; @48wks. relapse-free patients (98% vs 63%); relapse-free patients without receiving immunosuppressive therapies […]Read More