Alexion's main drug, Eculizumab, has been successful in clinical trials in Phase III
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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Alexion announced the success of its maindrug(Phase III ClinicalTrial
(PREVENT) on the Phase III ClinicalDisease (NMOSD), Eculizumab has been approved by the United States and the European Union for the treatment of patients with persevereed sleephetinhetitic urination (PNH) and atypical hemolytic uremic syndrome (aHUS)in the European Union, it is also approved as the first and only drug in patients with anti-acetylcholine receptor (AchR) antibody-positive severe muscle weakness (MG) and is also used in the United States to treat adult patients with anti-AchR antibodiesin China, on September 5, 2018, the StateDrug(the Supervisory Authority announced that Eculizumab Injection) has been approved in China for the treatment of adult and child haemophilic hemoglobinuria (PNH) and atypical hemolytic urethra syndrome (aHUS)Sales for the first half of 2018 were $1.7 billionAnd in the active expansion of other indications, this will enable Soliris (Eculizumab) to obtain more patient populations and significantly increase the commercial potentialrelated studies
a multi-country, double-blind, parallel group, time-event study conducted in patients with water channel protein-4 (AQP4) autoantibodies-positive NMOSD, assessed the efficacy and safety of Soliris relative to placeboIn the study, 143 adult NMSOD patients were randomly assigned Soliris and placebo treatment at a 2:1 ratio, with the main endpoint of the study being the first trial recurrence time assessed by an independent review committeePhase III clinical trial results show that the study reached its main endpoint Compared to placebo, Soliris (Eculizumab) treatment reduced the risk of NMOSD recurrence by 94.2% Ninety-nine percent of patients treated with Eculizumab did not relapse, compared with 63.2 percent of those treated with a placebo at the same time , the annual recurrence rate of patients treated with Eculizumab was significantly reduced by 95.5 percent to the critical sub-point of the trial The safety has been consistent with previous trial results, with the use of Soliris (Eculizumab) to treat NMSOD patients with significant results
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