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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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February 27, 2015
07:23 EDTALXNAlexion receives CHMP positive opinions for updates to EU label for Soliris
Alexion announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a Positive Opinion to update the therapeutic indication for Soliris in the treatment of paroxysmal nocturnal haemoglobinuria for patients with high disease activity regardless of history of transfusion. The CHMP also issued a Positive Opinion to update the EU label for Soliris with additional data on the benefits of long-term treatment and the risks associated with treatment discontinuation in patients with atypical haemolytic uremic syndrome. If approval is granted, updated information for the use of Soliris in both PNH and aHUS will be detailed in the Summary of Product Characteristics which will be published in the revised European Public Assessment Report. The CHMP based its opinion on efficacy and safety data from an observational, non-interventional international PNH Registry, which confirmed that patients with no history of transfusion who were treated with Soliris had a significant reduction in haemolysis and associated clinical symptoms, such as fatigue.
February 23, 2015
07:22 EDTALXNSunTrust to hold a conference
2015 Biotechnology and Pharmaceutical 1:1 Orphan Drug Day is being held in New York on February 23.
February 18, 2015
11:02 EDTALXNAlexion management to meet with SunTrust
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