Positive Phase III Results for Genentech’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in the New England Journal of Medicine

Stuart SchlossmanNMO (NMOSD/Devics)

Sunday – December 1, 2019

Satralizumab demonstrated robust efficacy, sustained for 144 weeks, in significantly reducing the risk of relapse in combination with baseline immunosuppressant therapy

Satralizumab targets the interleukin-6 (IL-6) receptor, a potential key driver of neuromyelitis optica spectrum disorder (NMOSD)
NMOSD is a rare, debilitating autoimmune disease of the central nervous system that can cause visual impairment, motor disability and even death

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that data from SAkuraSky, a pivotal Phase III study of the investigational medicine satralizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD), were published in the November 27, 2019 online issue of the New England Journal of Medicine (NEJM).
“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,” said Levi Garraway, M.D., Ph.D., 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 III 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.”
People with NMOSD experience unpredictable, severe relapses that directly cause cumulative, permanent, neurological damage and disability. The condition is often misdiagnosed as multiple sclerosis. Satralizumab inhibits interleukin-6 (IL-6) signaling, which is believed to play a key role in the inflammation that occurs in people with NMOSD. Satralizumab can be self-administered every four weeks by subcutaneous injection.

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