Navigation Links
Shire Presents Positive Efficacy and Safety Data for velaglucerase alfa in Treatment of Naive Patients With Type 1 Gaucher Disease
Date:2/11/2010

reported by at least 20% of all patients included headache, nasopharyngitis, injury, arthralgia, cough, pyrexia, dizziness, influenza, nasal congestion, vomiting, bone pain, and activated partial thromboplastin time (aPTT) prolonged. No drug-related serious adverse events were reported.  No patient withdrew from the study due to an adverse event. One patient developed antibodies to velaglucerase alfa.  

A subpopulation analysis of study TKT032 was conducted to assess the efficacy and safety of velaglucerase alfa among children aged 2-17. Of 25 patients in the trial, 7 pediatric patients (28%) were enrolled and randomized to receive velaglucerase alfa at 60 U/kg (n=4) or 45 U/kg (n=3) as a 1-hour infusion, every other week for 12 months. In this analysis the two dose groups were pooled and results are shown as a percent change from baseline.

Following 12 months treatment with velaglucerase alfa the mean hemoglobin concentration increased 20%, mean platelet counts increased 54%, mean spleen volume, normalized by body weight, decreased 47% (median value 5.0 multiples of normal (MN) decreased from 13.5 MN). Mean liver volume normalized by body weight decreased 13% (median value 1.04 MN decreased from 1.40 MN). Outcomes reported in children were consistent with those seen in the overall population. Due to the small sample sizes, the results did not achieve statistical significance.

Most frequently reported adverse events in the pediatric subpopulation were headache, nasopharyngitis, pyrexia, nasal congestion, productive cough, vomiting, and injury. No pediatric participants experienced severe or serious treatment-emergent events. No pediatric patients developed antibodies to velaglucerase alfa.

"We are very pleased with the opportunity to present the findings from the first of three Phase III studies for velaglucerase alfa," said Whaijen Soo, MD, PhD, Senior Vice President, Research and Development, Shire Hum
'/>"/>

SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Shire Submits Biologics License Application (BLA) for REPLAGAL(R) With the U.S. Food and Drug Administration (FDA)
2. Shire Expands its Award-Winning ADHD Support Resource, ADHDSupport.com, by Launching an ADHD Twitter(TM) Page
3. Shire and Teva Settle Litigation Concerning Supply of ADDERALL XR Authorized Generic
4. Shire Announces Publication of Open-Label Study on Coadministration of INTUNIV(TM) (guanfacine) Extended-Release Tablets with Stimulants
5. Shire Re-Launches FOCUS, an Online, Personalized Patient Support Program for Adults with ADHD Taking Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII
6. Shire Reports Tolerability and Clinical Effects Results of Daytrana(R) (methylphenidate transdermal system) from Study in Adolescents with ADHD
7. Shire Continues to Deliver Excellent Growth From Core Products
8. Shire to Present Important Study Findings on its ADHD Treatments at a Major Psychiatric Meeting on October 29 and 30
9. Shire Presents Results of Five Lialda(R) (mesalamine) Analyses at ACG 2009 Annual Scientific Meeting
10. Shire Targets Fourth Quarter Filing of BLA for REPLAGAL(R) for Fabry Disease With U.S. FDA
11. Shire and Sandoz Settle all Pending Litigation Concerning ADDERALL XR(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... Sept. 19, 2014 The American Association for ... Design and Manufacturing has joined the AAHomecare Corporate Partner ... Harvey Diamond have been actively involved in AAHomecare ... it has quickly grown into a major global manufacturer ... Drive allows AAHomecare to increase efforts on behalf of ...
(Date:9/19/2014)... UBM Medica US announces that  ... help oncologists and other clinicians gain a better understanding ... targeted therapies and immunotherapies, discusses some of the latest ... Every September, Blood Cancer Awareness Month ... blood cancers—helping to increase survival rates and improve the ...
(Date:9/19/2014)... 2014 Larry J. Merlo , President and ... speak before the National Press Club in Washington, ... move to stop selling tobacco products and its leadership in ... "Dramatic changes in our health care system pose ... Merlo has said. "CVS Health has a truly unique combination ...
Breaking Medicine Technology:Drive Medical Design & Manufacturing Joins AAHomecare Corporate Partner Program 2OncoTherapy Network Highlights National Blood Cancer Awareness Month 2OncoTherapy Network Highlights National Blood Cancer Awareness Month 3OncoTherapy Network Highlights National Blood Cancer Awareness Month 4CVS Health CEO to Address National Press Club on Landmark Decision to Quit Tobacco, Leadership in Health Care Innovation 2CVS Health CEO to Address National Press Club on Landmark Decision to Quit Tobacco, Leadership in Health Care Innovation 3
... Pharmaceutical Services is pleased to announce the exciting addition ... as the new Manager of Minerals.  Dr. Al-Ammar brings ...  Al-Ammar has over fourteen years of experience with ICP-MS ... the United States and Europe.  Additionally, Dr. Al-Ammar has ...
... MedNet Solutions, a global life sciences technology solutions company ... announce that MedNet will be showcasing its full lineup ... Association (DIA) Annual Meeting in Chicago, IL on June ... release of iMedNet EDC earlier this year, MedNet now ...
Cached Medicine Technology:Dr. Assad Al-Ammar Joins Irvine Pharmaceutical Services as the New Minerals Analysis Manager in Response to the Growing Needs for USP Elemental Impurities Testing 2MedNet Solutions to Showcase Its Complete Suite of eClinical Solutions at the 47th DIA Annual Meeting 2
(Date:9/19/2014)... women who live in leafy, green neighborhoods are less likely ... study suggests. Researchers analyzed data from more than 64,000 ... lived in a neighborhood with plenty of trees, grass and ... preterm birth (before 30 weeks) and a 13 percent lower ... Babies born to mothers who lived in greener neighborhoods were ...
(Date:9/19/2014)... HealthDay Reporter THURSDAY, Sept. 18, ... and family conflicts before surgery may face a higher ... suggests. Investigators found that patients with a so-called ... greater risk for complications compared to those with a ... known that patient quality of life is a complex ...
(Date:9/19/2014)... (PRWEB) September 19, 2014 MetroMD, a leading ... the “God Particle” of human health. This therapy has grown ... making the therapy more effective, safe and dependable. It has ... them an opportunity to live a very healthy and active ... concept of HGH therapy, a senior therapist at MetroMD said, ...
(Date:9/19/2014)... (PRWEB) September 19, 2014 In partnership with ... been an active part of the project’s social media efforts. ... which aims to re-define the perception of beauty as it ... began as an idea by Shelly Baer and Vanessa Silberman, ... women as sexy and beautiful. Ginny Dixon, Wendy Crawford, Susan ...
(Date:9/19/2014)... approaches to reducing poverty that help children and ... advocates, and foundations. By combining education and training ... jobs that offer a path out of poverty ... these programs aim to improve the life opportunities ... report from the National Center for Children in ...
Breaking Medicine News(10 mins):Health News:Do Greener Neighborhoods Produce Healthier Babies? 2Health News:Family Squabbles Can Derail Recovery From Cancer Surgery 2Health News:Family Squabbles Can Derail Recovery From Cancer Surgery 3Health News:MetroMD Announces Better HGH Therapy - the ‘God Particle’ of Human Health 2Health News:OC Healthcare Agency StudioPMG Partners with The Raw Beauty Project ™ NYC 2014 2Health News:A two generation lens: Current state policies fail to support families with young children 2
... cycles, known as circadian rhythms, are important for proper ... health. Disruptions of circadian rhythms and sleep-wake cycles have ... study by Douglas Institute researchers unravels a possible basis ... of clock genes in multiple areas of the human ...
... April, 2011: In the context of rising levels of cardiovascular ... of Cardiology (ESC) announces that for the first time- the ... Asia Pacific Congress of Cardiology (APCC). The 18th edition ... Malaysia, from 5 to 8 May 2011. The ESC deputation ...
... producing large quantities of a much-needed new imaging agent for ... other diseases, and the first evidence that the material is ... oxide nanoparticle, which is inexpensive, and stays in the body ... in the Journal of the American Chemical Society . ...
... a compound derived from tobacco, reduced plaques associated with dementia ... disease, a study led by researchers at Bay Pines VA ... The findings are reported online in the Journal ... "We found a compound that protects neurons, prevents the progression ...
... research shows that high maternal viral load and co-infection ... factors associated with vertical transmission of the hepatitis C ... (CC) is associated independently with the spontaneous clearance of ... in the mother or children did not increase risk ...
... -- Global Bridges, a healthcare alliance for tobacco dependence ... the InterAmerican Heart Foundation (IAHF) in Dallas, Texas, announced ... for health care providers in Latin America on how ... developed in collaboration with several regional and global expert ...
Cached Medicine News:Health News:Researchers observe disruptions of daily rhythms in Alzheimer's patients' brains 2Health News:The European Society of Cardiology organizes educational program in Asia 2Health News:Tobacco-derived compound prevents memory loss in Alzheimer's disease mice 2Health News:Severity of hepatitis C and HIV co-infection in mothers contribute to HCV transmission to child 2Health News:Health care alliance for tobacco dependence treatment launches training in Mexico 2Health News:Health care alliance for tobacco dependence treatment launches training in Mexico 3
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: