Viela's first new drug approved by FDA to treat optic neurospinal itis spectrum disease
Last Update: 2020-06-16
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Read: This is the second innovative treatment to date that has been approved by the FDA to treat this type of patientOn June 11, the U.SFDA announced the approval of Viela Bio's anti-CD19 monoclonal antibody Uplizna (inebilizumab-cdon) for the treatment of patients with the optic neurospinal corditis spectrum disease (NMOSD)These patients carry antibodies that target the AQP4 water channel proteinThis is the second innovative treatment to be approved by the FDA to treat such patients, and has been certified as an orphan drugIt is also the first innovative treatment approved by the FDA since Viela Bio was foundedIn NMOSD patients, the body's immune system mistakenly attacks healthy cells and proteins in the body, usually cells and proteins in the optic nerve and spinal cordPatients with NMOSD usually have an onset of optic neuritis, which can lead to eye pain and vision lossTransverse myelitis can also occur, often leading to numbness, weakness, and even paralysis of arms and legs, and loss of control of the bladder and intestinesMost seizures are clusters, sometimes to months to years, and then partially recover during the remission periodAbout 50% of NMOSD patients suffer from permanent vision impairment and paralysis due to NMOSD attacksWomen are more likely than men to be affected by NMOSD, while African Americans are more likely to develop NMOSD than whites, according to the National Institutes of HealthEstimates vary, but NMOSD is thought to affect between 4,000 and 8,000 patients in the United StatesNMOSD may be related to an antibody that binds to a protein called aquaporin-4 (AQP4)The combination of anti-AQP4 antibodies appears to activate other components of the immune system, leading to inflammation and damage to the central nervous systemThe effectiveness of Uplizna's treatment of NMOSD was confirmed in clinical studies in 230 adult patients, and the effectiveness and safety of intravenous Uplizna were evaluatedIn this trial, 213 out of 230 patients had anti-AQP4 antibodies (anti-AQP4 antibody positive) In the 197-day study, 161 anti-AQP4 antibody-positive patients received Uplizna treatment, and the risk of NMOSD recurrence was reduced by 77% compared to the placebo treatment group There is no evidence that patients who are negative against AQP4 antibodies have benefits Responsible Editor: Meng Meng statement: This article's views only on behalf of the author himself, not on behalf of the position of the drug intelligence network, welcome to exchange supplements in the message area; Related tags: U.S., NMOSD, Rare Disease0 0
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