
Roche’s satralizumab shows promise at Phase 3 in neuromyelitis optica spectrum disorder
pharmafile | December 2, 2019 | News story | Research and Development, Sales and Marketing | Roche, pharma, satralizumab
Roche has presented new data on its interleukin-6 (IL-6) inhibitor satralizumab in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a condition characterised by relapses which can lead to cumulative and permanent neurological damage and disability in affected patients.
Satralizumab can be self-administered once every four weeks via subcutaneous injection. In Phase 3 trials, 89% of patients receiving the therapy in combination with baseline immunosuppressant therapy were found to be relapse-free after 48 weeks of treatment; this finding extended to 78% and 74% of patients at week 96 and week 144, compared to 66%, 59% and 49% with placebo with baseline therapy.
Just eight of the 41 total participants receiving satralizumab plus baseline therapy reported a protocol-defined relapse (PDR), compared to 18 of the 42 placebo patients.
The study was also noted to be representative of the real-world adolescent and adult NMOSD community by including both aquaporin-4 seropositive and seronegative patients in its intent-to-treat population.
“The positive results from the pivotal SAkuraSky study of satralizumab support the hypothesis that IL-6 plays a key role in NMOSD, which is a debilitating and potentially fatal condition,” commented Dr Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “Satralizumab has shown robust efficacy sustained for 144 weeks across a broad patient population in two Phase 3 studies, whether given as a monotherapy or in combination with baseline therapy. We’re encouraged that satralizumab may soon provide a new treatment option for people living with NMOSD.”
Satralizumab is currently under review in Europe and the US with decisions expected next year.
Matt Fellows
Related Content

Roche adds 2,176 NVIDIA Blackwell GPUs to its hybrid-cloud AI factory
Roche has expanded its global AI infrastructure with a NVIDIA AI factory, adding 2,176 high-performance …

LGC Group opens $100M Organic Chemistry Synthesis Centre of Excellence
LGC Group, a life sciences company, has opened its new Organic Chemistry Synthesis Centre of …

Roche receives CE Mark for blood test to help rule out Alzheimer’s
Roche has been granted CE Mark approval for its Elecsys pTau181 test, the first in …






