Eculizumab News and Research

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Alexion begins eculizumab clinical trial in Shiga-toxin producing E. coli hemolytic uremic syndrome

Alexion Pharmaceuticals, Inc. and Alexion Pharma International Sàrl (APIS), announced today that the Paul-Ehrlich-Institut, Germany's healthcare regulatory body for biological products, has authorized initiation of an open-label clinical trial to investigate eculizumab as a treatment for patients with Shiga-toxin producing E. coli hemolytic uremic syndrome, which has resulted from infections by Enterohemorrhagic Escherichia coli in an unusually wide outbreak in Germany that began in May.

20 Jun 2011

Study reveals positive impact of Soliris on long-term outcomes in PNH patients

Alexion Pharmaceuticals, Inc. today announced the presentation of research that provides further insight into the clinical consequences of paroxysmal nocturnal hemoglobinuria (PNH), and positive impact of Soliris® (eculizumab) therapy on long-term outcomes.

13 Jun 2011

Final data from Alexion's Soliris Phase 2 studies on aHUS presented at EHA 2011

Alexion Pharmaceuticals, Inc. today announced the presentation of final data from the two Phase 2 studies of Soliris as a treatment for patients with atypical hemolytic uremic syndrome.

13 Jun 2011

Alexion's sBLA for Soliris receives FDA Priority Review designation to treat aHUS

Alexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has granted the Company's request for Priority Review of its supplemental Biologics License Application for Soliris as a treatment for patients with atypical Hemolytic Uremic Syndrome.

1 Jun 2011

Eculizumab effective for treating hemolytic-uremic syndrome from EHEC

In the online version of the New England Journal of Medicine, physicians and scientists in Heidelberg, Montreal, and Paris reported on the successful treatment of three young children who were suffering from a severe hemolytic-uremic syndrome after an infection with enterohemorrhagic Escherichia coli.

1 Jun 2011

Alexion first quarter non-GAAP net income increases to $56.3 million

Alexion Pharmaceuticals, Inc. today announced financial results for the three months ended March 31, 2011. Alexion Pharmaceuticals, Inc. reported net product sales of Soliris® (eculizumab) of $166.1 million, reflecting steady additions of new patients, compared to $117.6 million for the same period in 2010.

21 Apr 2011

Blood journal to publish Soliris study results in Paroxysmal Nocturnal Haemoglobinuria

The Canadian Association of PNH Patients welcomes the upcoming publication of a study that resoundingly proves the efficacy of Soliris, the first and only life-saving treatment for the ultra-rare blood disease known as Paroxysmal Nocturnal Haemoglobinuria.

11 Apr 2011

Alexion submits Soliris marketing applications to FDA, EMA for aHUS treatment

Alexion Pharmaceuticals, Inc. announced today that the company has submitted marketing applications to the U.S. Food and Drug Administration and the European Medicines Agency for Soliris as a treatment for patients with atypical Hemolytic Uremic Syndrome.

7 Apr 2011

Genetic errors in women linked to increased risk of preeclampsia

Scientists have identified genetic errors in women with autoimmune diseases that increase the risk of preeclampsia, a potentially life-threatening condition that occurs in 10 percent of all pregnancies.

23 Mar 2011

Alexion joins EURORDIS, NORD and medical communities to observe Rare Disease Day 2011

Alexion Pharmaceuticals, Inc. joins the European Organization for Rare Diseases, the National Organization for Rare Disorders and families, governments, companies and medical communities around the world in observing the fourth annual Rare Disease Day today.

28 Feb 2011

Alexion fourth quarter net product sales of Soliris increases to $156.0 million

Alexion Pharmaceuticals, Inc. today announced financial results for the quarter and year ended December 31, 2010. For the three months ended December 31, 2010, Alexion Pharmaceuticals, Inc. 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.

10 Feb 2011

Alexion acquires investigational therapy for MoCD Type A ultra-rare genetic disorder from Orphatec

Alexion Pharmaceuticals, Inc. announced that it has purchased patents and assets from Germany-based Orphatec Pharmaceuticals GmbH related to an investigational therapy for patients with molybdenum cofactor deficiency (MoCD) Type A, a devastating ultra-rare genetic disorder characterized by severe brain damage and rapid death in newborns.

10 Feb 2011

Alexion announces acquisition of Taligen Therapeutics

Alexion Pharmaceuticals, announced that it has acquired Taligen Therapeutics, a privately held development-stage biotechnology company based in Cambridge, Mass.

31 Jan 2011

Smoking cessation products available on PBS

Australia’s federal government has announced that it will subsidize the cost of nicotine patches to help smokers quit. The announcement was made by Health Minister Nicola Roxon on Thursday who said that concession card holders would be able to access Nicorette, Nicabate P and Nicotinell under the Pharmaceutical Benefits Scheme (PBS) from February 1, 2011. She said, “Cancer scars the lives of too many Australians and we know that reducing the smoking rate is one of the most effective ways to reduce the rate of death from this terrible disease.” Anti-smoking drug Varenicline (Champix) would also be available for willing quitters.

8 Dec 2010

New analysis of Soliris in patients with PNH presented at ASH Annual Meeting

Independent investigators reported today that patients with paroxysmal nocturnal hemoglobinuria who were treated long-term with Soliris (eculizumab) achieved survival comparable to that of an age- and gender-matched normal population. Findings from this investigator-led analysis were reported in an oral presentation today at the 52nd American Society of Hematology Annual Meeting and Exposition in Orlando.

7 Dec 2010

New analysis evaluates association between hemolysis, mortality in patients with PNH

Alexion Pharmaceuticals, Inc. today announced the presentation of an analysis from the National Data Registry in South Korea that evaluated the association between hemolysis and mortality in patients with paroxysmal nocturnal hemoglobinuria.

7 Dec 2010

Alexion Pharmaceuticals reports interim results from phase 1 trial on samalizumab antibody

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced the presentation of interim results from the first Phase I/II trial of samalizumab, the company's investigational, first-in-class humanized monoclonal antibody.

6 Dec 2010

Alexion's Soliris Phase 2 clinical study for aHUS meets primary, secondary endpoints

Alexion Pharmaceuticals, Inc. announced today that a Phase 2 clinical study investigating Soliris (eculizumab) as a treatment for patients with atypical Hemolytic Uremic Syndrome (aHUS) who are resistant to plasma therapy met primary and key secondary endpoints with high levels of statistical and clinical significance, according to results presented today at the American Society of Nephrology (ASN) annual meeting in Denver.

21 Nov 2010

New data on Soliris for PNH treatment to be presented at ASH Annual Meeting

Alexion Pharmaceuticals, Inc. today announced that researchers are scheduled to present new data relating to Soliris (eculizumab) as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) during the 52nd Annual Meeting of the American Society of Hematology (ASH), to be held December 4 - 7, 2010 at the Orange County Convention Center in Orlando.

9 Nov 2010

Alexion 2010 third quarter revenue increases from $102.6 to $141.6 million

Alexion Pharmaceuticals, Inc. today announced financial results for the three and nine months ended September 30, 2010.

21 Oct 2010