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NMOSD is a rare neurodegenerative central nervous system (CNS) autoimmune disease that affects hundreds of thousands of people worldwide. The main symptoms of
patients are inflammatory lesions in the optic nerve and spinal cord.
NMOSD patients often recur, and repeated attacks by the immune system on their own tissues can lead to progressive accumulation of nerve damage and disability.
patients experience decreased vision, motor function and quality of life, and severe NMOSD seizures can lead to death.
, there is no approved treatment for the disease.
Although NMOSD is thought to be a disease caused by the entry of autoimmune antibodies targeting AQP4 into CNS, about one-third of patients do not have autoimmune antibodies that target AQP4.
In recent years, inflammatory cytokine IL-6 is a new and important target in NMOSD pathology, which triggers inflammatory cascade reactions, leading to injury and disability. Enspryng, developed by
Roche, is a fully humanized IL-6 receptor monoclonal antibody.
it inhibits the IL-6 signaling pathway and inhibits the production of inflammation and the generation of autoimmune antibodies targeting AQP4.
Enspryng is injected every four weeks, making it a convenient treatment option for patients and caregivers.
the FDA has awarded the therapy breakthrough therapy.
. Enspryng's approval in Japan is based on the results of two key Phase 3 clinical studies.
they assessed the efficacy and safety of Enspryng as a monodrug therapy, and as an additional therapy other than standard care.
results of the trial showed that patients treated with Enspryng single drug had a 55 percent lower risk of recurrence compared to the placebo group.
, patients who received Enspryng monodrug with a 74 percent lower risk of recurrence in the subgroup of patients who carried AQP4 autoantibodies.
SAkuraSky's results showed that patients who received Enspryng combined with standard therapy had a 62 percent lower risk of recurrence compared to the placebo group.
patients who received Enspryng combined with standard therapy had a 79 percent lower risk of recurrence in subgroups carrying AQP4 autoantibodies.
" today's approval is the first time Enspryng has been approved in Asia, providing a new treatment option for patients with NMOSD to reduce recurrence.
these relapses can eventually lead to irreversible disabilities, including blindness and paralysis," said Dr. Levi Garraway, Roche's chief medical officer and head of global product development.
"