Chugai Reports Results of P-III SAkuraStar Study of Satralizumab for Neuromyelitis Optica Spectrum Disorder

Chugai Reports Results of P-III SAkuraStar Study of Satralizumab for Neuromyelitis Optica Spectrum Disorder

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 of time to first protocol-defined relapse, relapse free patients @ 48, 96 & 144wks. (76.1%, 72.1% & 62.8% vs 61.9%, 51.2% and 34.1)
  • Satralizumab is an anti-IL-6 receptor recycling Ab, evaluated in two P-III study in NMO and NMOSD patients and has achieved 1EPs as an add-on therapy to immunosuppressant or as monothx. The US FDA and EMA has accepted the regulatory application of the therapy and the company has filed the regulatory application in Japan in 2019

Click here ­to­ read full press release/ article | Ref: Chugai | Image: The Business Times