U.S. FDA APPROVES SOLIRIS (ECULIZUMAB) FOR TREATMENT OF PSYNOPHONIC INFLAMMATORY SPECTRUM DISEASE
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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NMOSD is a rare central nervous disease in which patients experience unpredictable recurrences that exacerbate the condition, gradually leading to blindness and paralysis, and even respiratory failure and premature deathrecently announced in the u.s(http://of Alexion Pharmaceuticals, a newdrughttp:// that its first C5 tonic inhibitor, Soliris (eculizumab), was accepted by the U.SFDA(http://to treat neurospinal itisenitis spectrum disease (NMOSD)At the same time, the FDA granted it priority review qualifications, which are expected to be approved in JuneSoliris (eculizumab) is a "first-in-class" supplement inhibitor that works by suppressing the C5 protein in the complement cascade reaction terminalprior to the, Soliris has been approved in several countries to treat rare and complementary diseases related to the tonic, such as haemoglobinuria (PNH), atypical hemolytic urethra syndrome (aHUS), and anti-acetylcholine receptor-positive severe muscle weakness (anti-AchR-gMG)The accepted sBLA is based on clinical phase 3trial(http:// data called PREVENT The trial used a double-blind, placebo-controlled, and the safety and efficacy of eculizumab was assessed in patients with relapsed AQP4 antibody-positive NMOSD, with positive results, and Soliris treatment reduced the risk of NMOSD recurrence by 94.2% Soliris is eligible for orphan drug treatment for NMOSD in the United States, the European Union and Japan
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