Navigation Links
FDA Approves Soliris for Rare Pediatric Blood Disorder
Date:9/23/2011

SILVER SPRING, Md., Sept. 23, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Soliris (eculizumab) to treat patients with atypical Hemolytic Uremic Syndrome (aHUS), a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Atypical HUS accounts for 5 to 10 percent of all cases of hemolytic uremic syndrome. The disease disproportionately affects children.

Soliris is a targeted therapy that works by inhibiting proteins that play a role in aHUS.  The FDA first approved Soliris in March 2007 to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare type of blood disorder that can lead to disability and premature death.  Soliris is classified as an orphan drug. Orphan drugs are those that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.

There are no other FDA-approved treatments for aHUS, and the safety and effectiveness of current standard treatment, plasma therapy (plasma exchange or fresh frozen plasma infusion), have not been studied in well controlled trials.

"This is the first approval of a drug for treating this life-threatening disease, and the first approval for use of Soliris in children," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "This approval underscores how an increased understanding of the biology of a disease and of how a drug interacts with that process can expedite drug development."

Soliris' safety and effectiveness were established in two single-arm trials in 37 adults and adolescent patients with aHUS and one retrospective study in 19 pediatric patients and 11 adult patients with aHUS.  Patients treated with Soliri
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
2. FDA Approves Xalkori with Companion Diagnostic for a Type of Late-stage Lung Cancer
3. FDA Approves Firazyr To Treat Acute Attacks of Hereditary Angioedema
4. FDA Approves Adcetris to Treat Two Types of Lymphoma
5. FDA Approves the First Specific Treatment for Scorpion Stings
6. Cardinal Health Board of Directors Approves Cash Dividend, Elects David P. King as Director
7. FDA Tentatively Approves Intellijects Lead Product, e-cue™
8. FDA Approves New Medicine BRILINTA™ (Ticagrelor) for Use in the US
9. FDA Approves Vaccines for the 2011-2012 Influenza Season
10. FDA Approves Boostrix to Prevent Tetanus, Diphtheria, and Pertussis in Older People
11. FDA Approves Arcapta Neohaler to Treat Chronic Obstructive Pulmonary Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... Dec. 18, 2014  Decision Resources Group finds that ... States will increase to a value of ... driven by expansion in the large direct energy device ... be increasingly adopted due to the advantages they offer ... key findings from Decision Resources Group,s coverage of the ...
(Date:12/19/2014)... Ky. , Dec. 18, 2014 Baptist Health ... States to receive full Atrial Fibrillation with Electrophysiology ... Care (SCPC). Atrial fibrillation is the most common ... that in some cases can lead to stroke and possible ... United States have atrial fibrillation and the numbers ...
(Date:12/19/2014)... and LYON, France , Dec. 19, ... LLY ) and Adocia (Euronext Paris: FR0011184241 – ADOC) ... an ultra-rapid insulin, known as BioChaperone Lispro, for treatment ... BioChaperone Lispro relies on Adocia,s proprietary BioChaperone® technology and ... and Adocia will develop BioChaperone Lispro with the goal ...
Breaking Medicine Technology:U.S. Laparoscopic Device Market Will Reach Over $4.3 Billion by 2023 2U.S. Laparoscopic Device Market Will Reach Over $4.3 Billion by 2023 3Baptist Health Lexington First in the Nation to Receive Atrial Fibrillation with EPS Accreditation 2Baptist Health Lexington First in the Nation to Receive Atrial Fibrillation with EPS Accreditation 3Lilly and Adocia Announce Alliance to Co-Develop Ultra-Rapid Insulin Based on BioChaperone Technology 2Lilly and Adocia Announce Alliance to Co-Develop Ultra-Rapid Insulin Based on BioChaperone Technology 3
(Date:12/19/2014)... 19, 2014 Energy Textiles is ... now available. Celliant, the world’s leading responsive textile, ... pillowcases. , There are a number of benefits ... increased oxygenation and balanced body temperature; which can ... pain relief; enhanced athletic performance; and overall wellness. ...
(Date:12/19/2014)... Santa Rosa, CA (PRWEB) December 19, 2014 ... 2x4 and 5x5 SuperClone Rooms. SuperCloset continues to offer ... grow solutions. Pair one of the new SuperClone Rooms ... truly professional, perpetual, and turnkey indoor hydroponic grow room ... cloner in the world, SuperCloset’s SuperPonic SuperCloner 50 ...
(Date:12/19/2014)... 2014 An evening dress is perfect for ... closet. Discount-Dress.com, a distinguished dresses retailer, has unveiled its new ... in this great shopping platform. Customers can view ... hard work, Discount-Dress.com has been accepted and praised by customers ... easier shopping stage for clients. In order to expand its ...
(Date:12/19/2014)... (HealthDay News) -- New research warns parents that buying an older ... Nearly half of teen drivers killed in the United States ... 11 years old and often lacked important safety features that are ... teen drivers killed in crashes were in cars at least six ... old, 31 percent were in cars 11 to 15 years old, ...
(Date:12/19/2014)... -- Potentially illness-causing E. coli bacteria were found on ... to a new study. Researchers checked cilantro, basil ... markets in Los Angeles and Orange counties in California, ... samples tested, 24 percent were positive for E. coli. ... researchers. Both types of bacteria can cause sometimes ...
Breaking Medicine News(10 mins):Health News:Energy Textiles Launches Celliant Revitalizing Bedsheets 2Health News:SuperCloset Continues to Innovate with New Complete Indoor Grow Room Packages, The SuperClone Rooms are the Newest Addition to the Award Winning SuperRoom Lineup 2Health News:Attractive Evening Dresses Announced by Discount-Dress.com 2Health News:Older Cars a Bad Choice for Younger Drivers 2Health News:E. Coli Germs Found on Farmers Market Herbs 2
... pass,companion bill and send measure to President, ALBANY, ... of the Protecting the Medicaid Safety Net Act of,2008, ... The bill,prevents massive increases in costs for people in ... "Today,s vote is a victory for all New York ...
... antibiotics sufficient to treat eye disease, study finds ... communities with moderate levels of the eye disease trachoma, ... with the antibiotic azithromycin may be sufficient to eliminate ... at the London School of Hygiene & Tropical Medicine,s ...
... needed to prove that oversulfated chondroitin sulphate caused deaths, ... researchers say they,ve confirmed that lots of the blood ... a man-made chemical called oversulfated chondroitin sulfate. , ... Biotechnology . , And, according to a paper published ...
... at the Congressional Gold Medal ceremony in the Capitol ... Below are the,Speaker,s remarks:, "Good morning. It is ... the House and Senate to honor Dr. Michael DeBakey. ... Representative Al,Green, and others who worked with them for ...
... 75-cent Per Pack Increase Would Help Raise $390 ... Ohio leaders should,fund a proposed economic stimulus plan ... prevention funds, recommends a report released,today by the ... this tobacco tax alternative would reduce smoking, save ...
... Corporation,(NYSE: STE ) today announced that its Board ... amount of $0.06 per common share. The,dividend is payable ... close of,business on May 14, 2008., About STERIS, ... a healthier today and,safer tomorrow through knowledgeable people and ...
Cached Medicine News:Health News:AARP Thanks New York's Representatives for Supporting Bill to Protect People in Medicaid 2Health News:Annual Trachoma Treatments May Be Unnecessary 2Health News:Researchers Identify Contaminant in Tainted Heparin 2Health News:Researchers Identify Contaminant in Tainted Heparin 3Health News:Pelosi: 'By Literally Fixing Broken Hearts, Dr. DeBakey Has Given Hope and Health to Millions' 2Health News:New Report: Increasing Ohio's Tobacco Tax Would Fund Economic Stimulus Plan and Preserve Highly-Successful Tobacco Prevention Program 2Health News:New Report: Increasing Ohio's Tobacco Tax Would Fund Economic Stimulus Plan and Preserve Highly-Successful Tobacco Prevention Program 3Health News:New Report: Increasing Ohio's Tobacco Tax Would Fund Economic Stimulus Plan and Preserve Highly-Successful Tobacco Prevention Program 4Health News:STERIS Corporation Declares Regular Quarterly Dividend 2Health News:STERIS Corporation Declares Regular Quarterly Dividend 3
... Triad Plus PVP-I Prep Gel ... PVP-I Prep Gel is film forming, ... action that has been known to ... gram-positive bacteria (including antibiotic resistant), fungi, ...
... HIBICLENS bonds with ... a protective, germ-killing field. ... fast acting antimicrobial effect, ... irritation potential promotes compliance ...
Aplicare's disposable 1-ounce pouches are designed for individual application and are ideal for reducing waste. They are used in nursing homes, home healthcare settings, blood banks, laboratories, em...
Aplicare's disposable 1-ounce pouches are designed for individual application and are ideal for reducing waste. They are used in nursing homes, home healthcare settings, blood banks, laboratories, em...
Medicine Products: