Chugai Pharmaceutical announced that the new drug application was approved by the Ministry of Health, Labour and Welfare (MHLW) for the pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody, Enspryng subcutaneous injection 120 mg Syringe (satralizumab) for the prevention of relapses of neuromyelitis optica spectrum disorder (including neuromyelitis optica). Enspryng was granted orphan drug designation in September 2019 and filed in November 2019.
“Neuromyelitis Optica Spectrum Disorder (NMOSD) is a chronic autoimmune disease with limited treatment options and high unmet medical needs which causes visual impairment and motor disability in severe unpredictable relapse. Enspryng is an antibody drug with a novel mechanism of action to inhibit the signaling of IL-6, an inflammatory cytokine that is a key driver in NMOSD, and shown to be highly effective in prevention of relapse of NMOSD,” said Dr. Osamu Okuda, Chugai’s president and COO. “In addition, Enspryng, which was the first to apply our proprietary recycling antibody technology, can be subcutaneously administered every four weeks for convenience. We are confident that Enspryng will widely contribute to the treatment of people with NMOSD as a new treatment option.”
This approval is based on the results from 2 global phase III clinical studies in patients with NMOSD: SAkuraSky Study and SAkuraStar Study. SAkuraSky is a study to evaluate Enspryng in combination with baseline immunosuppressive treatment, and SAkuraStar is a study to evaluate Enspryng as monotherapy.
Enspryng, created by Chugai, is the pH-dependent binding humanized anti-IL-6 receptor antibody, which was the first to apply our proprietary recycling antibody technology. The drug is believed to prevent relapse of NMOSD by inhibiting IL-6 signal signaling which is a key driver in NMOSD. Enspryng was approved in Canada for the first time in the world. Enspryng is designated as an orphan drug for the treatment of neuromyelitis optica (NMO) and NMOSD in Japan, and for the treatment of the same disease group in Europe and the US. In addition, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the treatment in December 2018. The application was accepted for review by the European Medicines Agency and the US FDA in 2019. Regulatory application in Japan was filed in November 2019.
NMOSD is an autoimmune disease of the central nervous system characterized by inflammatory lesions in the optic nerves and spinal cord, and cause continual and significant decrease in quality of life due to permanent neurological disability. Patients with NMOSD frequently experience a relapsing disease course with repeated attacks leading to accumulating neurological damage and disability. Symptoms may include visual impairment, motor disability, and pain leading to decreased quality of life. In some cases, attacks of NMOSD result in death. Aquaporin-4 antibodies (AQP4-IgG), pathogenic antibodies, are detected in at least two-thirds of NMOSD people. AQP4-IgG is known to target and damage a specific central nervous cell type called astrocytes, resulting in inflammatory demyelinating lesions of the optic nerves, spinal cord and brain. The inflammatory cytokine IL-6 is now emerging as an important factor in NMOSD pathogenesis.