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 PBO in 95 & 83 patients aged 20-70 &  13-73yrs. in a ratio (2:1) & (1:1) administered at week 0-2 & 4 in patients with NMOSD respectively
• In overall population: reduction in the risk of relapse (62% & 55%); In the pre-specified subgroup of AQP4-IgG seropositive patients: reduction in the risk of relapse (79% & 74%) respectively
• Enspryng is a mAb targeting IL-6 and is under PR in Canada for NMOSD patients who are AQP4-IgG seropositive. In Oct’2019- the FDA & EMA has accepted the MAA for the therapy with expected CHMP & FDA’s decision in 2020

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 Ref: Roche  | Image: Roche