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

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