Shots: The company reported the data from the N-MOmentum trial involves assessing Uplizna in patients with NMOSD The results from the N-MOmentum trial demonstrated a reduction in pain, long-term safety, […]readmore
Tags : Neuromyelitis Optica Spectrum Disorder
Biotech
Regulatory
Roche’s Enspryng (satralizumab) Receives Health Canada Approval for Neuromyelitis Optica
Shots: The approval is based on two P-III studies: The SAkuraStar & SAkuraSky studies involves assessing Enspryng as monothx. and in combination with IST vs PBO in 95 & 83 […]readmore
Biotech
Regulatory
Roche’s Enspryng (satralizumab-mwge) Receives the US FDA’s Approval for Neuromyelitis
Shots: The approval is supported by P-III SAkuraStar and SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx. & as an add-on therapy to baseline IST vs PBO […]readmore
Biotech
Regulatory
Roche’s Enspryng (satralizumab) Receives MHLW’s Approval for Neuromyelitis Optica Spectrum
Shots: The approval is based on two P-III SAkuraStar & SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx & as an add-on therapy to baseline IST vs […]readmore
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 […]readmore
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 […]readmore
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 […]readmore
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 […]readmore
Regulatory
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 […]readmore