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Today, Roche announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved the launch of Enspryng,an IL-6 receptor inhibitor developed by the company to prevent the recurrence of disease in adults and children with the disease of the visual neurospinal corditis spectrum disorder (NMOSD)These patients carry antibodies against AQP4This is the first time the innovative treatment has been approved in Asia, Roche has submitted applications for the new drug to the United States, the European Union and China, and its listing in China has been included in the proposed priority application list, which is expected to accelerate the introduction of the innovative treatment in ChinaNMOSD is a rare neurodegenerative central nervous system (CNS) autoimmune disease that affects hundreds of thousands of people worldwideThe main symptoms of the patient are inflammatory lesions in the optic nerve and spinal cordPatients with NMOSD often experience relapse of the disease, and repeated attacks by the immune system on their own tissues can lead to progressive accumulation of nerve damage and disabilityPatients experience decreased vision, motor function and quality of life, and severe NMOSD seizures can lead to deathCurrently, there is no approved treatment for the diseaseAlthough 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 AQP4In recent years, inflammatory cytokine IL-6 has been an emerging and important target in NMOSD pathology, triggering an inflammatory cascade reaction that leads to injury and disabilityThe Enspryng developed by Roche is a fully humanized IL-6 receptor monoclonal antibodyIt inhibits the IL-6 signaling pathway and inhibits the production of inflammation and the generation of autoimmune antibodies targeting AQP4Enspryng is an easy treatment option for patients and caregivers with subcutaneous injections every four weeksThe FDA has awarded the therapy breakthrough therapyEnspryng's approval in Japan is based on the results of two key Phase 3 clinical studiesThey assessed the efficacy and safety of Enspryng as a monodrug therapy, and as an additional therapy other than standard careThe results showed that the results of the SakuraStar showed that patients treated with Enspryng monodrug had a 55 percent lower risk of recurrence compared to the placebo group In addition, patients who received Enspryng monodrug therapy had a 74% lower risk of recurrence in the subgroup of patients who carried AQP4 autoantibodies SAkuraSky's results showed that patients who received Enspryng and standard therapy had a 62 percent lower risk of recurrence compared to the placebo group In subgroups carrying AQP4 autoantibodies, patients who received enspryng combined with standard therapy had a 79% lower risk of recurrence " 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 "
.