FDA approves Alexion's intravenous drug Soliris (eculizumab) for treatment of NMOSD

recently, the u.SFood andDrug(http://Regulatory Authorityhttp://
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of the intravenous drug Soliris (http:// for the treatment of ostospinal cordisive syndrome in adult patients with a positive antibody in combination with water channel protein-4 (AQP4)About Soliris
Soliris is a C5 complement inhibitor developed by Alexion to reduce inflammatory responseby by inhibiting the C5 protein in the complement cascade reaction terminalPreviously, it was first approved by the FDA in 2007 for the treatment of rare and complementary diseases related to tonics such as haemoglobinuria (PNH), atypical hemolytic urethra syndrome (aHUS), and anti-acetylcholine receptor antibody-positive severe muscle weakness (anti-AchR-gMG)The effectiveness of Soliris treatment of NMOSD was confirmed in a 48-week clinical study involving 143 NMOSD patients who tested positive for AQP4 antibodies and were randomly treated with Soliris or placebocompared to placebo therapy, the study showed that Soliris treatment reduced the number of relapses in NMOSD patients by 94%It also reduces the need for patients to be hospitalized and to treat acute episodes with corticosteroids or plasma replacementsafetythe FDA issued a black-box warning for Soliris that patients treated with Soliris should be identified and treated early in life-threatening meningococcal infections that could be life-threatening or fatalUse should monitor the patient's early symptoms of meningococcal infection and, if an infection is suspected, should be evaluated immediatelyPatients with severe meningococcal infectionshould should stop using itHealthMedical(http://professionals should also exercise caution when giving Soliris to any other infected patientno cases of meningococcal infection have been observed in the nMOSD ClinicalTrial(http://In NMOSD clinical trials, the most common adverse reactions reported by patients were: upper respiratory tract infection, common cold (nasopharyngitis), diarrhea, back pain, dizziness, influenza, joint pain, sore throat (pharyngitis) and bruising