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NMOSD is a rare inoperative central nervous system (CNS) autoimmune disease that affects hundreds of thousands of people worldwide and is often misdiagnosed as multiple sclerosis, mainly damaging the optic nerve and spinal cord, leading to blindness, muscle weakness and paralysis.
patients with NMOSD often have a recurrence of the disease, and repeated attacks by the immune system on their own tissues can lead to the gradual accumulation of nerve damage and disability.
can experience decreased vision, motor function and quality of life, and severe NMOSD seizures can lead to death.
Enspryng is the only leukocytic mesoblast-6 (IL-6) monoantiotherapy approved for NMOSD, and the IL-6 signaling path plays a key role in the associated inflammation caused by NMOSD.
Enspryng uses a new recycling antibody technology designed to extend the antibody cycle time to once every four weeks, and can be given at home by NMOSD patients or caregivers after medical training.
FDA's approval is based on the results of two randomized controlled Phase 3 clinical trials, SakuraStar and SakuraSky, one of the largest critical clinical trials for NMOSD.
Enspryng showed strong and consistent efficacy and good safety characteristics in adult patients with AQP4 antibody-positive NMOSD.
Enspryng single-drug therapy and in association with baseline immunosuppressant therapy (IST), the risk of recurrence was significantly reduced compared to placebo, and the efficacy lasted 96 weeks.
baseline immunosuppressant therapy (IST) is commonly used to treat the recurrence of NMOSD.
SakuraStar study showed that 76.5 percent of patients in the AQP4 antibody-positive subgroup who received Enspryng single-drug treatment did not relapse at 96 weeks, up from 41.1 percent in the placebo group.
in the SakuraSky study, which evaluated Enspryng in cooperation with BaselineIST, 91.1 percent of AQP4 antibody-positive patients treated with Enspryng had no recurrence at 96 weeks, compared with 56.8 percent in the placebo group.
: s1. FDA Approves Genentech's Enspryng for Neuromyelitis Optica Spectrum Disorder. Retrieved 2020-08-15, from.
