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

s in these studies experienced a favorable improvement in kidney function, including elimination of the requirement for dialysis in several patients with aHUS that did not respond to plasma therapy. Patients treated with Soliris also exhibited improvement in platelet counts and other blood parameters that correlate with aHUS disease activity.

The most common side effects seen in patients treated with Soliris for aHUS included high blood pressure (hypertension), diarrhea, headache, anemia, vomiting, nausea, upper respiratory and urinary tract infections, and a decrease in white blood cells (leukopenia).

This new indication for Soliris is being approved with an extension of the existing Risk Evaluation and Mitigation Strategy (REMS), to inform health care professionals and patients about the known risk of life-threatening meningococcal infections.

Soliris will continue to be available only through a restricted program, and prescribers must enroll in a registration program and provide a medication guide to patients who receive the drug.

Soliris was reviewed under the FDA's priority review program, which provides for an expedited six-month review of drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists.

The therapy also is being approved under the FDA's accelerated approval program, designed to provide patients with earlier access to promising new drugs followed by further studies to confirm the drug's clinical benefit.

The accelerated approval program allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on an endpoint that is reasonably likely to predict a clinical benefit to patients, or on an effect on a clinical endpoint other than survival or irreversible morbidity.

Soliris is marketed by Alexion Pharmaceuticals in Cheshire, Conn.

For more information:

FDA: Office of Hematology
'/>"/>

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:1/15/2014)... PHILADELPHIA , Jan. 15, 2014  Echo Therapeutics, Inc. ... company developing its Symphony® CGM System as a non-invasive, ... Robert F. Doman , Executive Chairman and Interim CEO ... Capital Markets, Tenth Annual Equity Conference. ...
(Date:1/15/2014)... Jan. 15, 2014 Reportlinker.com announces that ... in its catalogue: ... and Market Analysis to 2022 ... Dermatitis - India Drug Forecast and Market ...
(Date:1/15/2014)... 2014  Zafgen, Inc., a leading biopharmaceutical company dedicated ... patients, today announced initial results from its Phase ... methionine aminopeptidase 2 (MetAP2), in patients with Prader-Willi ...  These results showed improvements in body weight, hunger-related ...
Breaking Medicine Technology:Echo Therapeutics to Present at the Noble Financial Capital Markets' Tenth Annual Equity Conference 2Echo Therapeutics to Present at the Noble Financial Capital Markets' Tenth Annual Equity Conference 3PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 2PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 3PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 4PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 5Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 2Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 3Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 4
... The current model for care of people with ... could bring devastating consequences not only the United States ... as diabetes is now the most significant public health ... On the crux of Diabetes Awareness Month, three ...
... Technologies, a developer and manufacturer of custom fluid-handling components ... a new range of hydrophilic, polyurethane foams for Advanced ... fair in Dusseldorf, Germany from 16 to 18 November ... New innovations to be featured at the show ...
Cached Medicine Technology:Global Trend in Diabetes Could Exact Catastrophic Toll on Emerging Global Healthcare Systems 2Global Trend in Diabetes Could Exact Catastrophic Toll on Emerging Global Healthcare Systems 3Global Trend in Diabetes Could Exact Catastrophic Toll on Emerging Global Healthcare Systems 4Filtrona Porous Technologies to Introduce New Hydrophilic Foam Products for Advanced Wound Care at the MEDICA / COMPAMED Trade Fair 2
(Date:4/23/2014)... of endogenous neural precursor cells cannot alone compensate ... the perspective of neural plasticity, Dr. Yun Xiang ... observed the effects of functional electrical stimulation treatment ... of basic fibroblast growth factor and epidermal growth ... side. The researchers found that functional electrical stimulation ...
(Date:4/22/2014)... (Chicago) A recently FDA-approved device has been shown ... as much as 50 percent. When coupled with an ... Rush, the device facilitated the complete elimination of seizures ... in the decade-long clinical trials. , That,s good news ... in the U.S. living with epilepsy whose seizures can,t ...
(Date:4/22/2014)... all lung cancers are small cell lung cancers ... to chemotherapy. However, researchers at Virginia Commonwealth University ... the mechanisms leading to this resistance that may ... primarily by mediating B-cell lymphoma 2 (Bcl-2) family ... Depending on their function, this family of proteins ...
(Date:4/22/2014)... Hopkins scientists have found a way to block abnormal ... of atherosclerosis, the main cause of heart attacks and ... The condition develops when fat builds inside blood vessels ... greatly reducing their ability to feed oxygen-rich blood to ... series of experiments, described April 7 in the journal ...
(Date:4/22/2014)... massive health care spending, a new RAND study concludes ... incentivize pharmaceutical companies and device makers to develop products ... medical technologies and their use, a new study suggests ... medical devices get created in the first place. The ... as little loss of health as possible and to ...
Breaking Medicine News(10 mins):Health News:Newly approved brain stimulator offers hope for individuals with uncontrolled epilepsy 2Health News:Scientists pinpoint protein that could improve small cell lung cancer therapies 2Health News:Scientists alter fat metabolism in animals to prevent most common type of heart disease 2Health News:Scientists alter fat metabolism in animals to prevent most common type of heart disease 3Health News:Scientists alter fat metabolism in animals to prevent most common type of heart disease 4Health News:US medical innovation needs smarter incentives to cut health spending, study finds 2Health News:US medical innovation needs smarter incentives to cut health spending, study finds 3
... (fool) has a lip smacking meaning here. Like Ekta ... nomenclature of the restaurants// here attracts customers. ... (Big Fool)", "Sabse Bada Bewakoof" (The Biggest Fool) and ... ,"The word 'bewakoof' is the only reason for ...
... An Israeli scientist wants to turn camel milk, a healthier ... desert.,The practised method of milking normally yields// some 1.5 litres ... the yield of 20 litres produced by cows. Yagil, however, ... 15 litres per camel a day. ,Traditionally seen ...
... organize a nationwide peaceful demonstration against the reservation quota in ... proposal to hike reservation seats started on the 27th April. ... by after the assembly poll in five states was not ... 2 will be a ‘‘show of strength’’ and send the ...
... in Angola to contain the cholera outbreak there says that 20,000 ... is an acute intestinal infection, which is caused in most cases ... It’s showing even more in other provinces now also. This week ... day and in some days more than 30 deaths," said Richard ...
... journal Nature has found that Gene therapy, which is used ... cancer//. US researcher, citing an animal study say that the ... than previously thought. ,However, experts from Great Ormond ... say that gene therapy in low doses does not cause ...
... the capital of India medical students are striking against ... new step when the students said that they are ... ,They were persuading school and college students to ... to increase the Other Backward Classes (OBC) quota in ...
Cached Medicine News:Health News:Milking the ship of the desert for 'white gold' 2Health News:Nationwide Strike on May 2nd by Medicos on Reservation Issue 2Health News:'Bubble Boy' Gene Therapy Causes Cancer? 2
Fine pointed grooved jaws with smooth curve from tip to finger grip style handle. Dull finish....
This forcep was designed to eliminate the occasional tearing of tissue which may occur when grasping the lips of an incision with a traditional. 12 forceps. The rows of blunt teeth are gentle yet pro...
Straight shafts with 1 x 2 teeth. Flat handle with polished finish....
Straight shafts with 90 degrees, 2 x 3 teeth and tying platform. Serrated handle with polished finish. Most popular size or model....
Medicine Products: