Alexion myasthenia gravis drug soliris is certified as an orphan drug by FDA
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Last Update: 2014-06-19
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Source: Internet
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Author: User
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Source: Ding Xiangyuan announced on June 17, 2014 that the FDA designated soliris (ekuzumab) as an orphan drug for the treatment of myasthenia gravis (mg) In January, the drug received a similar confirmation to prevent renal failure in kidney transplant patients Mackay, global research and development director of the company, said: "the complement activation end pathway is considered to play an important role in the pathophysiological process of myasthenia gravis Soliris can specifically inhibit this pathway, so we believe that soliris has the potential to help patients with this rare and destructive disease." The pharmaceutical company said it is currently recruiting people to participate in the trials of placebo group and soliris group in the treatment of refractory systemic mg At present, no country in the world has approved soliris for Mg treatment, the company said The drug has been approved in the United States, the European Union, Japan and other countries to treat paroxysmal sleep hemoglobinuria According to the efficacy of the drug, FDA and European regulatory agencies, as well as Japan and other countries later expanded the approval of the drug for the treatment of atypical hemolytic uremic syndrome Earlier, alexion pointed out that sales of soliris rose 67% in the first quarter, compared with $567 million in the same period last year Original link: http:// TSID = 28 & region_id = 2
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