Roche's Enspryng Receives EC's Approval as First Home Subcutaneous Treatment for NMOSD
Shots:
- The approval is based on two P- III studies i.e SAkuraStar & SAkuraSky study evaluating the efficacy and safety of Enspryng (SC- q4w) as monothx. & in combination with IST vs PBO in adults aged 12yrs. with AQP4-IgG seropositive with NMOSD respectively
- SAkuraStar results: in AQP4-IgG seropositive subgroup- relapse free patients @48wks. & @96wks. (83% vs 55% & 77% vs 41%). SAkuraSky results: in AQP4-IgG seropositive relapse free patients @48wks. & @96wks. (92% vs 60% & 53%) respectively
- Enspryng is the 1st approved therapy for NMOSD targeting IL-6R receptor. The company is working with reimbursement and health technology assessment bodies in EU to provide access to Enspryng
Ref: Globe Newswire | Image: Roche
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