Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that
researchers will present seven posters detailing findings from clinical
studies of Soliris® (eculizumab) in patients with atypical
hemolytic uremic syndrome (aHUS) as well as from the Global aHUS
Registry at the annual meeting of the American Society of Nephrology
(ASN), being held November 11-16, 2014, in Philadelphia. aHUS is a
genetic, chronic, ultra-rare disease associated with vital organ failure
and premature death. Abstracts summarizing these presentations, which
enhance the understanding of aHUS to provide optimal care for patients,
were published on the ASN website and can be accessed using the links
below.
Soliris, a first-in-class terminal complement inhibitor, is approved in
nearly 40 countries as a treatment for patients with aHUS and in nearly
50 countries as a treatment for patients with paroxysmal nocturnal
hemoglobinuria (PNH), a debilitating, ultra-rare and life-threatening
blood disorder characterized by complement-mediated hemolysis
(destruction of red blood cells). Both aHUS and PNH are caused by
chronic uncontrolled complement activation.
The following abstracts will be presented in a poster session on
Saturday, November 15, 2014, from 10:00 a.m. to 12:00 p.m., Eastern
Standard Time (EST):
Abstract 783: “Eculizumab Inhibits Thrombotic Microangiopathy and
Improves Renal Function in Adult Atypical Hemolytic Uremic Syndrome
Patients: 1-Year Update,” Fakhouri, et al.
Accessible at: http://www.abstracts2view.com/asn_2014/view.php?nu=783&type=abstract
Abstract 1667: “Characteristics of 406 Adult and Pediatric Patients in
the Global aHUS Registry,” Licht, et al.
Accessible at: http://www.abstracts2view.com/asn_2014/view.php?nu=1667&type=abstract
Abstract 1952: “Time to End-Stage Renal Disease in Patients With
Atypical Hemolytic Uremic Syndrome Receiving Supportive Care and
Eculizumab,” Khursigara, et al.
Accessible at: http://www.abstracts2view.com/asn_2014/view.php?nu=1952&type=abstract
Abstract 2703: “Eculizumab Reduces Terminal Complement, Complement
Alternative Pathway Activation, Inflammation, Endothelial Damage,
Thrombosis and Renal Injury Markers in Patients With Atypical Hemolytic
Uremic Syndrome,” Cofiell, et al.
Accessible at: http://www.abstracts2view.com/asn_2014/view.php?nu=2703&type=abstract
Abstract 1915: “Safety and Efficacy of Eculizumab in Pediatric Patients
With aHUS, With or Without Baseline Dialysis,” Vande Walle, et al.
Accessible at: http://www.abstracts2view.com/asn_2014/view.php?nu=1915&type=abstract
Abstract 2728: “Safety and Efficacy of Eculizumab in Adult aHUS
Patients, With or Without a History of Renal Transplant,” Loirat, et al.
Accessible at: http://www.abstracts2view.com/asn_2014/view.php?nu=2728&type=abstract
Abstract 2726: “Eculizumab Safety and Efficacy in Adult Patients With
aHUS, With or Without Baseline Dialysis,” Fakhouri, et al.
Accessible at: http://www.abstracts2view.com/asn_2014/view.php?nu=2726&type=abstract
About Soliris® (eculizumab)
Soliris is a first-in-class terminal complement inhibitor developed from
the laboratory through regulatory approval and commercialization by
Alexion. Soliris is approved in the U.S. (2007), European Union (2007),
Japan (2010) and other countries as the first and only treatment for
patients with paroxysmal nocturnal hemoglobinuria (PNH), a debilitating,
ultra-rare and life-threatening blood disorder, characterized by
complement-mediated hemolysis (destruction of red blood cells). Soliris
is indicated to reduce hemolysis. Soliris is also approved in the U.S.
(2011), the European Union (2011), Japan (2013) and other countries as
the first and only treatment for patients with atypical hemolytic uremic
syndrome (aHUS), a debilitating, ultra-rare and life-threatening genetic
disorder characterized by complement-mediated thrombotic
microangiopathy, or TMA (blood clots in small vessels). Soliris is
indicated to inhibit complement-mediated TMA. The effectiveness of
Soliris in aHUS is based on its effects on TMA and renal function.
Soliris is not indicated for the treatment of patients with Shiga-toxin E.
coli-related hemolytic uremic syndrome (STEC-HUS). For the
breakthrough medical innovation in complement inhibition, Alexion and
Soliris have received some of the pharmaceutical industry's highest
honors: the Prix Galien USA (2008, Best Biotechnology Product) and
France (2009, Rare Disease Treatment).
More information including the full U.S. prescribing information on
Soliris is available at www.soliris.net.
Important Safety Information
The U.S. product label for Soliris includes a boxed warning:
"Life-threatening and fatal meningococcal infections have occurred in
patients treated with Soliris. Meningococcal infection may become
rapidly life-threatening or fatal if not recognized and treated early
[see Warnings and Precautions (5.1)]. Comply with the most current
Advisory Committee on Immunization Practices (ACIP) recommendations for
meningococcal vaccination in patients with complement deficiencies.
Immunize patients with a meningococcal vaccine at least two weeks prior
to administering the first dose of Soliris, unless the risks of delaying
Soliris therapy outweigh the risk of developing a meningococcal
infection. [See Warnings and Precautions (5.1) for additional guidance
on the management of the risk of meningococcal infection]. Monitor
patients for early signs of meningococcal infections and evaluate
immediately if infection is suspected. Soliris is available only through
a restricted program under a Risk Evaluation and Mitigation Strategy
(REMS). Under the Soliris REMS, prescribers must enroll in the program
[see Warnings and Precautions (5.2)]. Enrollment in the Soliris REMS
program and additional information are available by telephone:
1-888-SOLIRIS (1-888-765-4747)."
In patients with PNH, the most frequently reported adverse events
observed with Soliris treatment in clinical studies were headache,
nasopharyngitis (runny nose), back pain and nausea. Soliris treatment of
patients with PNH should not alter anticoagulant management because the
effect of withdrawal of anticoagulant therapy during Soliris treatment
has not been established. In patients with aHUS, the most frequently
reported adverse events observed with Soliris treatment in clinical
studies were headache, diarrhea, hypertension, upper respiratory
infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough,
peripheral edema, nausea, urinary tract infections, pyrexia. Soliris is
not indicated for the treatment of patients with Shiga-toxin E.
coli-related hemolytic uremic syndrome (STEC-HUS). Please see full
prescribing information for Soliris, including BOXED WARNING regarding
risk of serious meningococcal infection.
About Alexion
Alexion is a biopharmaceutical company focused on serving patients with
severe and rare disorders through the innovation, development and
commercialization of life-transforming therapeutic products. Alexion is
the global leader in complement inhibition and has developed and markets
Soliris® (eculizumab) as a treatment for patients with
paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic
syndrome (aHUS), two debilitating, ultra-rare and life-threatening
disorders caused by chronic uncontrolled complement activation. Soliris
is currently approved in nearly 50 countries for the treatment of PNH
and in nearly 40 countries for the treatment of aHUS. Alexion is
evaluating other potential indications for Soliris in additional severe
and ultra-rare disorders beyond PNH and aHUS, and is developing other
highly innovative biotechnology product candidates, including asfotase
alfa, across multiple therapeutic areas. This press release and further
information about Alexion can be found at: www.alexionpharma.com.
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