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January 23, 2013
14:55 EDTALXNAlexion informed Health Ministers will not follow AGNSS Soliris recommendation
Alexion Pharma UK, a subsidiary of Alexion Pharmaceuticals, announced it has been informed by the National Specialised Commissioning Team that the Ministers of Health have decided to not follow a positive recommendation by the Advisory Group for National Specialised Services, or AGNSS, when assessing Soliris as a treatment for patients with atypical haemolytic uraemic syndrome. The Ministers of Health have overruled this expert committee recommendation and instead referred consideration of Soliris for the treatment of patients with aHUS to the National Institute for Health and Clinical Excellence. Alexion said it is committed to working with the Health Ministers to make Soliris available to children and adults as quickly as possible, and calls upon the Ministers to accept the recommendation of the significant number of experts and lay people called upon to review Soliris without delay, and to reverse his decision and accept the recommendation of AGNSS in the best interests of aHUS patients in England. Alexion said, "It is important to underscore that the UK Government developed a specific process and authorised a committee, AGNSS, to evaluate treatments addressing patients with very rare disorders, and that AGNSS concluded that 'eculizumab should be routinely nationally commissioned for 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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