- New data demonstrate ENSPRYNG’s robust and sustained longer-term efficacy in preventing relapses in people with neuromyelitis optica spectrum disorder (NMOSD)
- More than 70% of people treated with ENSPRYNG remained relapse-free after four years in the SAkuraStar (73%) and SAkuraSky (71%) open-label extension (OLE) studies, with a favourable safety profile
- ENSPRYNG is now approved in 58 countries, including
the United States, Canada, Japan, South Koreaand the European Union
“The positive longer-term efficacy and safety results for ENSPRYNG are important for physicians as they consider ENSPRYNG as a treatment option for their patients,” said Prof. Dr.
The pivotal SAkuraStar and SAkuraSky four year OLE data found that 73% and 71% of people with AQP4-IgG seropositive NMOSD treated with ENSPRYNG remained relapse-free after 192 weeks (3.7 years), respectively, and 90% and 91% remained free from severe relapse*. These results demonstrate that the robust efficacy observed in the studies' double-blind periods is sustained longer-term for ENSPRYNG as both a monotherapy and in combination with immunosuppressive therapy.
The data also demonstrate a favourable safety and tolerability profile for ENSPRYNG in the overall ENSPRYNG treatment period of up to seven years, comparable to the double-blind treatment periods in both SAkuraStar and SAkuraSky studies. Rates of adverse events and serious adverse events during the overall treatment periods were consistent with ENSPRYNG and placebo in the double-blind periods.
The most common adverse reactions observed were: headache, arthralgia, white blood cell count decrease, hyperlipidaemia, and injection-related reactions. No new safety signals were observed.
“We are pleased that these longer-term data further reinforce the previously observed efficacy and safety of ENSPRYNG, which was specifically designed for this lifelong, chronic disease by targeting the IL-6 pathway to reduce the frequency of relapses,” said
ENSPRYNG is the first and only NMOSD treatment administered subcutaneously every four weeks, allowing for home-dosing and increasing flexibility and convenience for people with NMOSD. ENSPRYNG is approved in 58 countries, including
About SAkuraStar and SAkuraSky in NMOSD
ENSPRYNG has been investigated in two pivotal Phase III studies in neuromyelitis optica spectrum disorder (NMOSD), with the primary endpoint of both studies being time to first protocol-defined relapse (PDR) adjudicated by an independent review committee in the double-blind period. In the open-label extension (OLE) periods of the SAkura studies, PDRs were determined by the investigator.
The Phase III SAkuraStar study evaluated the efficacy and safety of ENSPRYNG monotherapy administered to adults with NMOSD. In the anti-aquaporin-4 antibody (AQP4-IgG) seropositive subgroup, 83% treated with ENSPRYNG remained relapse-free at 48 weeks, compared with 55% of those treated with placebo. At 96 weeks, 77% of those treated with ENSPRYNG remained relapse-free, compared with 41% with placebo.
The Phase III SAkuraSky study evaluated the efficacy and safety of ENSPRYNG in combination with baseline immunosuppressive therapy in adults and adolescents with NMOSD. Overall, 92% of AQP4-IgG seropositive participants receiving ENSPRYNG in combination with immunosuppressive therapy remained relapse-free at 48 and 96 weeks, compared with 60% and 53% with placebo, respectively.
ENSPRYNG showed a favourable safety and tolerability profile in the Phase III studies. The most common adverse reactions observed were: headache, arthralgia, white blood cell count decrease, hyperlipidaemia and injection-related reactions.
About neuromyelitis optica spectrum disorder (NMOSD)
NMOSD is a rare, lifelong and debilitating autoimmune condition of the central nervous system that primarily damages the optic nerve(s) and spinal cord, causing permanent blindness, muscle weakness and paralysis. People with NMOSD experience unpredictable, severe relapses directly causing cumulative, permanent, neurological damage and disability. In some cases, relapse can result in death. NMOSD affects over 10,000 people in
NMOSD is commonly associated with pathogenic antibodies (AQP4-IgG) that target and damage a specific cell type, called astrocytes, resulting in inflammatory lesions of the optic nerve(s), spinal cord and brain. AQP4-IgG antibodies are detectable in the blood serum of around 70-80% of people with NMOSD.
Although most cases of NMOSD can be confirmed through diagnostic tests, people living with the condition are still frequently misdiagnosed with multiple sclerosis. This is due to overlapping characteristics of the two disorders, including a higher prevalence in women, similar symptoms and the fact that people can experience relapses in both conditions.
About ENSPRYNG® (satralizumab)
ENSPRYNG, which was designed by Chugai, a member of the
Positive Phase III results for ENSPRYNG, as both monotherapy and in combination with baseline immunosuppressive therapy, suggest that IL-6 inhibition is an effective therapeutic approach for NMOSD. The Phase III clinical development programme for ENSPRYNG included two studies: SAkuraStar and SAkuraSky.
ENSPRYNG is currently approved in 58 countries, including
ENSPRYNG has been designated as an orphan drug in
Neuroscience is a major focus of research and development at
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*Relapse associated with low likelihood of recovery, resulting in permanent disability
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