Alexion Pharmaceuticals, Inc.(NASDAQ:ALXN) Gets EU Approval for therapeutic indication of Soliris |
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By David Fowler |
Friday, 10 April 2015 13:35 |
The update strengthens the fact that transfusions don’t affect underlying disease process in PNH and haemolysis plays key role in disease. The non typical haemolytic uraemic syndrome (aHUS) section of EU label has got updated for including the fresh efficiency data which specifies that long-term treatment with Soliris was related to more proportion of patients getting clinically significant benefits and new information on risks pertaining to treatment discontinuation. When European Medicines Agency (EMA) had approved Soliris in 2011, the Clinical Particulars section had said that the treatment is recommended for continuing throughout the patient's lifetime until discontinuation is indicated. The revised label adds that monitoring may not be sufficient for preventing severe thrombotic microangiopathy complications in patients who do not continue with Soliris treatment Carsten Thiel, Ph.D., SVP, EMEA and Asia-Pacific, Alexion, said that the label updates comprise of vital information which help in optimising care for patients with aHUS and PNH, two very rare as well as life-threatening disorders. He added patients that for patients having PNH, the new label confirms that patients at high risk of morbidities or premature mortality is likely to get benefit from the treatment. Shares of the company jumped 2.50% to $181.80. "Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'. Add this page to your favorite Social Bookmarking websites ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() |