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November 4, 2012
11:34 EDTALXNAlexion:Data show long-term benefits of chronic Soliris therapy in aHUS patients
Alexion Pharmaceuticals announced the presentation of two-year data that highlight the long-term benefits of chronic Soliris, eculizumab, therapy in patients with atypical hemolytic uremic syndrome, aHUS, an ultra-rare genetic disease characterized by thrombotic microangiopathy, TMA, the formation of blood clots in small blood vessels throughout the body. In two pivotal phase 2 studies, which initially enrolled 37 patients, 32 patients entered a long-term extension phase. The data demonstrated that ongoing Soliris treatment for two years was associated with sustained inhibition of complement-mediated TMA, as indicated by a maintained increase in platelet count, and sustained improvement in renal function and TMA event-free status.1,2 The data were presented today at Kidney Week 2012, the annual meeting of the American Society of Nephrology, ASN, in San Diego. Additionally, data presented in a poster session at ASN support early initiation of Soliris therapy regardless of the presence or absence of genetic mutations in patients with aHUS.
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November 27, 2014
08:15 EDTALXNAlexion says NICE recommends Soliris for aHUS patients
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November 25, 2014
06:35 EDTALXNAlexion's Soliris granted ODD in Japan
Alexion Pharmaceuticals announced that Soliris, or eculizumab, has been granted orphan drug designation, or ODD, by Japanís Ministry of Health, Labour and Welfare for the treatment of patients with neuromyelitis optica, or NMO, a life-threatening, ultra-rare neurologic disorder. In patients with NMO, chronic, uncontrolled complement activation results in severe damage to the central nervous system, predominantly impacting the optic nerve and spinal cord.1-3 This devastating disease is characterized by severe weakness, paralysis, respiratory failure, loss of bowel and bladder function, blindness and premature death.4-6
November 20, 2014
07:09 EDTALXNAlexion management to meet with Deutsche Bank
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November 19, 2014
10:28 EDTALXNAlexion management to meet with Deutsche Bank
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November 18, 2014
07:52 EDTALXNFDA Drug Safety & Risk Management Advisory Committee to hold a meeting
The Committee discusses the risk management of Alexion Pharmaceuticals' Eculizumab (Soliris) is a meeting being held at FDA Silver Spring, Maryland offices on November 18 at 9 am. Webcast Link
November 16, 2014
13:04 EDTALXNAlexion says data supports effectiveness of sustained Soliris treatment in aHUS
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