Soliris, generically known as eculizumab, is the first approved treatment for aHUS. ❋ Unknown (2011)
Food and Drug Administration cleared the medicine Soliris, chemically known as eculizumab, for atypical hemolytic uremic syndrome on the condition the company conducts additional clinical trials to confirm the medicine's benefit, the Cheshire, Connecticut-based company said in a statement.
Shares of Alexion Pharmaceuticals rose 31% last week after the Cheshire, Conn.-based company reported positive late-stage results for eculizumab, an experimental anemia drug. ❋ Unknown (2006)
Soliris® eculizumab, Alexion's first marketed product, is approved in more than 35 countries as a therapy for patients with PNH, a debilitating and ultra-rare life-threatening blood disorder.
("Alexion", or the "Company") reported net product sales of Soliris ® (eculizumab) of $156.0 million, reflecting strong additions of new patients, compared to $110.6 million for the same period in 2009.
What carries the load for Alexion Pharma is its flagship drug Soliris eculizumab.
The post goes on to say: "Alexion stressed in its filing that eculizumab is not approved for the treatment of STEC-HUS in Germany or elsewhere ... the drug maker said it is supplying Soliris at no charge to physicians who request it for STEC-HUS patients."
During the fourth quarter of 2010, Alexion made significant progress on advancing the development of eculizumab as a treatment for patients suffering from additional rare and severe complement-mediated disorders beyond PNH, with a focus on its two lead nephrology programs in aHUS and transplant.
Alexion is now planning two global, company-sponsored controlled clinical trials evaluating eculizumab to prevent AHR in patients undergoing kidney transplant.
In November 2010, researchers at the American Society of Nephrology (ASN) annual meeting in Denver presented positive data from the Company's two Phase 2 26-week studies of eculizumab as a treatment for adult and adolescent patients with aHUS. aHUS is an ultra-rare, chronic and life-threatening disease in which uncontrolled complement activation causes blood clots in small blood vessels throughout the body (thrombotic microangiopathy, or TMA) leading to kidney failure, stroke, heart attack and death.
Alexion Treating Europe's E Coli Victims, notes: "Alexion reports Tuesday in its 8-K filing to the Securities and Exchange Commission that its German subsidiary has been deluged with physician requests for eculizumab - branded as Soliris - to treat patients suffering from Shiga-toxin producing E. coli hemolytic uremic syndrome STEC-HUS."
The Company has completed dosing in these two Phase 2 clinical studies of eculizumab as an investigational treatment for patients with aHUS.
Soliris eculizumab is not approved for the treatment of aHUS or any indication other than PNH.
Part 1 of 2: A video discussion between Dr. Harry S. Jacob and Dr. Wendell F. Rosse about the paradigm shift that eculizumab (S.liris) has brought to treatment of paroxysmal nocturnal hemoglobinuria. photo: Creative Commons/jenifgrr ❋ Unknown (2010)
Soliris® (eculizumab) net product sales increased 36 percent to $125.8 million in ❋ Unknown (2010)
Alexion's accelerated plans for the launch of Soliris in Japan are based on recent approval of the price for Soliris® (eculizumab) in Japan by an advisory committee of Japan's Ministry of Health, Labour and Welfare (MHLW). ❋ Unknown (2010)
Alexion is evaluating other potential indications for Soliris as well as other formulations of eculizumab for additional clinical indications, and is pursuing development of other antibody product candidates in early stages of development. ❋ Unknown (2010)
Pharmaceuticals, Inc. (Nasdaq: ALXN) and Alexion Pharma International Sàrl today announced that the launch of Soliris (eculizumab) as a treatment for patients with PNH in Japan will begin in the third quarter of 2010, approximately three months earlier than previously expected. ❋ Unknown (2010)
Part 1 of 2: A video discussion between Dr. Harry S. Jacob and Dr. Wendell F. Rosse about the paradigm shift that eculizumab (S.liris) has brought to treatment of paroxysmal nocturnal hemoglobinuria. ❋ Unknown (2010)
