Navigation Links
Alexion Reports Positive Results from AEGIS Registration Study of Soliris in Japanese Patients With PNH
Date:12/8/2008

from the AEGIS study in an application for marketing authorization to be submitted to the PMDA in 2009. The Company has begun to establish its commercial organization in Japan in anticipation of a commercial launch of Soliris in that country in 2010.

About PNH

PNH is a rare blood disorder that affects an estimated 8,000 to 10,000 people in North America and Europe and, using similar prevalence estimates, potentially 1,000 - 2,000 patients in Japan. (4) PNH strikes people of all ages, with an average age of onset in the early 30s. (5) Approximately 10 percent of all patients first develop symptoms at 21 years of age or younger. (6) PNH develops without warning and can occur in men and women of all races, backgrounds and ages. PNH often goes unrecognized, with delays in diagnosis ranging from one to more than 10 years. (7) The estimated median survival for PNH patients is between 10 and 15 years from the time of diagnosis. (5,7)

PNH has been identified more commonly among patients with disorders of the bone marrow, including aplastic anemia (AA) and myelodysplastic syndromes (MDS). (8,9,10) In patients with thrombosis of unknown origin, PNH may be an underlying cause. (6,11)

Prior to approval of Soliris, there were no therapies specifically available for the treatment of PNH. PNH treatment was limited to symptom management through periodic blood transfusions, non-specific immunosuppressive therapy and, infrequently, bone marrow transplantations -- a procedure that carries considerable mortality risk. (6,11)

About Soliris

Soliris was approved in March 2007 by the U.S. Food and Drug Administration (FDA) as the first treatment for PNH, a rare, debilitating and life-threatening blood disorder defined by hemolysis, or the destruction of red blood cells. In June 2007, the European Commission (EC) also approved the use of Soliris for the treatment of patients with PNH.
'/>"/>

SOURCE Alexion Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Alexion Secures U.S. Patent for ALXN6000, a First-In-Class Anti-CD200 Monoclonal Antibody
2. Alexion Completes Enrollment in AEGIS Registration Study of Soliris(R) (eculizumab) in Patients with PNH in Japan
3. Alexion Commences Dosing in AEGIS Registration Study of Soliris(R) (eculizumab) in Patients with PNH in Japan
4. Rib-X Pharmaceuticals Reports Positive Top-Line Results from Phase 2 Study of Delafloxacin
5. GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet Counts and Reduced Bleeding in Long-Term Study of Patients With Chronic ITP
6. Schering-Plough Reports Preladenant Meets Primary Endpoint in Phase II Dose-Finding Trial for Parkinsons Disease
7. GEN Reports on the Trend Toward Predictive Toxicogenomics
8. Vical Completes Enrollment and Reports Positive Interim Data in CMV Vaccine Phase 2 Trial
9. SCOLR Pharma, Inc. Reports Third Quarter 2008 Financial Results
10. Cadence Pharmaceuticals Reports Third Quarter 2008 Financial Results and Provides Clinical Development Programs Update
11. Bavarian Nordic Reports Successful Safety Data From Phase II Study With IMVAMUNE(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... "Copay coupons," a drug manufacturer ... drugs among patients with prescription drug coverage, may now be ... report  from the Department of Health and ... anti-kickback laws prohibit suppliers from offering side-payments to ... the federal government. The report ...
(Date:9/19/2014)... 2014 Today, iHealth Lab Inc. announced it has ... for its first institutional round of funding. The strategic ... reach, accelerate growth and innovation, and invest in additional ... Xiaomi Ventures will join iHealth,s board of directors, bringing ... ecommerce. "We are very pleased to have ...
(Date:9/19/2014)... -- Kiromic, LLC, a Lubbock bio-pharmaceutical ... the former chancellor of Texas Tech University, to its board ... 2014, after raising $1.2 billion for the university. ... the most successful chancellor in the history of Texas Tech ... investor, but also as our new vice chairman of the ...
Breaking Medicine Technology:PCMA: New OIG Report Cites Drug Manufacturer "Copay Coupon" Use in Medicare Part D 2iHealth Raises $25 Million to Fuel Growth and Global Market Share 2Former Texas Tech Chancellor Named New Vice Chairman of the Board of Kiromic, LLC 2
... 23, 2011 Starpharma Holdings Limited (ASX: SPL, OTCQX: ... 2 clinical study that demonstrated efficacy of VivaGel(R) for ... Key Points: VivaGel(R) meets primary ... VivaGel(R) expected to avoid many shortcomings of existing therapies ...
... in Guilford is one of six Maine companies recently honored ... employees, and to manufacturing or service excellence, with the 21st ... by the Maine Department of Economic and Community Development, the ... 17 at the State House in the Hall of Flags. ...
Cached Medicine Technology:VivaGel(R) Demonstrates Efficacy in Bacterial Vaginosis 2VivaGel(R) Demonstrates Efficacy in Bacterial Vaginosis 3VivaGel(R) Demonstrates Efficacy in Bacterial Vaginosis 4VivaGel(R) Demonstrates Efficacy in Bacterial Vaginosis 5Hardwood Products Wins Formal Acclaim From Gov. LePage for Excellence and Community Commitment 2Hardwood Products Wins Formal Acclaim From Gov. LePage for Excellence and Community Commitment 3
(Date:9/20/2014)... York, New York (PRWEB) September 20, 2014 ... filings continue to grow in federal court, Bernstein ... Food & Drug Administration (FDA) have voted overwhelmingly ... low testosterone in men be subjected to further ... According to a report published on September 18th ...
(Date:9/20/2014)... 19, 2014 (HealthDay News) -- The avian flu that ... could be spread through respiratory drops and therefore poses ... study. Although no human illnesses have been linked ... Children,s Research hospital have discovered natural mutations to the ... travel through the air in droplets. Current seasonal ...
(Date:9/20/2014)... September 20, 2014 Ticket Down ... concert tickets for her 2015 “Honeymoon Tour.” This well-known ... for added savings. , In early 2015, fans will have ... the world across North America. Twenty-one-year-old Ariana Grande will hit ... will take her to 25 cities across the United States ...
(Date:9/20/2014)... September 20, 2014 iFitDress.com, the popular ... for women, has recently unveiled its new collection of ... sale for special offer on these new outfits; it ... season. All customers can now buy cheap cocktail ... company’s sales representative says, “We have extensive experience in ...
(Date:9/20/2014)... have advised their patients against drinking coffee and wine. Dr. ... advice and changing his stance after considering two recent studies ... health. “There’s good news and great news,” says Dr. Wells, ... against gum disease, and red wine can help fight cavities!” ... September 2014 issue of Boston University School of Medicine ...
Breaking Medicine News(10 mins):Health News:As Testosterone Lawsuits Grow, Bernstein Liebhard LLP Notes Overwhelming Vote Calling for Further Study of Testosterone Heart Risks 2Health News:As Testosterone Lawsuits Grow, Bernstein Liebhard LLP Notes Overwhelming Vote Calling for Further Study of Testosterone Heart Risks 3Health News:Avian Flu In Harbor Seals Could Infect People 2Health News:Ariana Grande Tickets in New York, Philadelphia, Orlando, Fairfax, Worcester, Toronto, Uncasville, Detroit, Miami, Pittsburgh, Cleveland, and Atlanta On Sale Today 2Health News:Ariana Grande Tickets in New York, Philadelphia, Orlando, Fairfax, Worcester, Toronto, Uncasville, Detroit, Miami, Pittsburgh, Cleveland, and Atlanta On Sale Today 3Health News:Fashionable Cocktail Dresses Unveiled Online at iFitDress.com 2Health News:South Charlotte Dentist, Dr. James Wells, is Changing His Advice on Coffee and Wine Drinking 2Health News:South Charlotte Dentist, Dr. James Wells, is Changing His Advice on Coffee and Wine Drinking 3
... HealthDay Reporter , TUESDAY, March 6 (HealthDay News) -- ... have significantly less asthma and allergies than Swiss children who ... What,s more, the Amish youngsters even have less ... up on non-Amish farms. The study could support ...
... TUESDAY, March 6 (HealthDay News) -- A smoking ban ... underweight babies, a new study finds. The nationwide ban ... The researchers analyzed data on preterm delivery and small-for-gestational-age babies ... of mothers who smoked dropped from more than 25 percent ...
... , TUESDAY, March 6 (HealthDay News) -- Vitamin D deficiency ... with an increased risk of death, a new study finds. ... vitamin D deficiency, according to lead author Dr. Stefan Pilz, ... Their study of nearly 1,000 female nursing home residents, ...
... patients in the United States remain in care consistently, according ... the University of Pennsylvania published online this week in ... is the first to provide a comprehensive national estimate of ... most likely to continue their treatment over time. "Helping ...
... March 6, 2012 Dr. Eric Olson ... UT Southwestern Medical Center, has won the 2012 Passano ... development of the heart and other muscles. In ... that Dr. Olson,s discoveries at the interface of developmental ...
... York, NY (March 5, 2012) Today, the ... Accelerating Cancer Cures Research Symposium, focused on rebuilding ... laboratory discoveries into new cancer therapies. The event, ... scientists and other leading pharmaceutical companies, including Eli ...
Cached Medicine News:Health News:Amish Farm Kids Have Lower Asthma, Allergy Risk: Study 2Health News:Amish Farm Kids Have Lower Asthma, Allergy Risk: Study 3Health News:Amish Farm Kids Have Lower Asthma, Allergy Risk: Study 4Health News:Lack of Vitamin D May Harm Older Women's Health 2Health News:1 in 4 US HIV patients don't stay in care, Penn study shows 2Health News:1 in 4 US HIV patients don't stay in care, Penn study shows 3Health News:Olson, noted UT Southwestern molecular biologist, wins 2012 Passano Award 2Health News:Olson, noted UT Southwestern molecular biologist, wins 2012 Passano Award 3Health News:Industry leaders join together for historic Accelerating Cancer Cures Research Symposium 2
... an option beyond traditional methods for ... low back pain. The new Orthotrac,Pneumatic ... chronic back pain. In fact, associated ... of application.,The Orthotrac is the only ...
Optical Urethrotome for Telescope 1.9 mm for neonates and children....
Optical Urethrotome for Telescope 2.7 mm for children....
Optical Mini Urethrotome for telescope 3.3 mm, 0...
Medicine Products: