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    Home > Medical News > Latest Medical News > Congratulate! Viela Bio's first new drug approved by FDA is less than two and a half years since the company was founded.

    Congratulate! Viela Bio's first new drug approved by FDA is less than two and a half years since the company was founded.

    • Last Update: 2020-06-16
    • Source: Internet
    • Author: User
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    NMOSD is a rare and severe neuroinflammatory autoimmune diseaseEighty percent of NMOSD patients produce autoantibodies (autoantibody) of a channel protein called AQP4 in the bodyThese autoantibodies targeting AQP4 are mainly combined with astrocytes from the central nervous system, triggering attacks on the optic nerve, the spinal cord, and the myelin that protect nerves in the brainSymptoms of the patient include vision loss, paralysis, nerve pain, and even respiratory failureEach Outbreak of NMOSD causes more damage to the nervous system and makes the patient's disability worseThere is no cure for the diseaseViela Bio was founded with the goal of targeting the co-communication pathways in severe inflammatory diseases and autoimmune diseasesIn an interview with the content team of the company, DrYao Zhengbin, the company's chief executive, pointed out that common signaling pathways are common in more than 80 autoimmune diseasesSo, for a disease, if you can develop a new drug that targets a specific signaling pathway, it has the potential to be therapeutic in the associated diseaseInebilizumab is a humanized monoclonal antibody that is highly affinitus to CD19CD19 is expressed on a variety of B cells, including plasma blasts and plasma cells that secrete antibodiesBy binding to the CD19 antigen, inebilizumab is able to quickly remove these cells from the blood circulation, thereby reducing the production of autoantibodies and alleviating the patient's symptomsThis innovative treatment has been approved by the FDA as a breakthrough therapyThe approval is based on the results of a key clinical trial called N-MomentumIn the study, 230 patients were randomly treated with ebilizumab monodrug therapy or placeboThese patients included 213 AQP4 antibody-positive NMOSD patients The results showed that Inebilizumab reached the primary endpoint of the trial, reducing the risk of NMOSD attack by 77% in patients who were positive against AQP4 antibody compared to placebo (HR: 0.227; p0.0001) After 6 months of treatment, 89% of anti-AQP4 antibody-positive patients did not have a seizure, compared with 58% in the control group Given that autoantibodies secreted by B cells also play an important role in a variety of other diseases, Viela Bio has filed an IND application with the FDA to initiate Phase 3 critical and Phase 2b clinical trials in patients with severe muscle weakness and IgG4-related diseases to test the effectiveness of inebilizumab At present, the company's research and development pipeline also has two in the clinical development stage of research therapy VIB4920 is designed to inhibit the cd40/CD40L co-stimulation pathway, while VIB7734 targets the innate cytokine pathway and inhibits the overproduction of inflammatory cytokines In March 2018, Dr Yao Zhengbin said in an interview with the pharmaceutical mingkant content team that in five years' time, even if only one new drug in the company's research pipeline were approved to reach patients, it would be a great success for them We congratulate Viela Bio on reaching this milestone ahead of time and wish them every effort to develop more innovative treatments that change the lives of patients.
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