- 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 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
- The studies demonstrated robust efficacy and a favorable safety profile in adults with AQP4 Ab positive NMOSD. relapse-free patients @96wks. (76.5% & 91.1% vs 41.1% & 56.8%)
- Enspryng is the first and only FDA-approved SC treatment option for AQP4 Ab positive NMOSD that can be self-administered by a patient or a caregiver every four weeks. The therapy is mAb targeting IL-6 that utilizes recycling antibody technology and will be available in the US in two wks.
Click here to read full press release/ article | Ref: Roche | Image: HKU E-Learning Platform