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:1/15/2014)... , Jan. 15, 2014  Celsion Corporation (the "Company") (NASDAQ: ... commitments from institutional investors to purchase an aggregate of ... an at-the-market registered direct offering, led by a dedicated ... definitive purchase agreements with these investors pursuant to which ...
(Date:1/15/2014)... , Jan. 15, 2014  Humberto C. Antunes,  Galderma  ... Award" from the Journal of Drugs in Dermatology ... Clinical Conference (ODAC). The event is January 17-20, 2014, at the ... . The ODAC is a ...
(Date:1/15/2014)... Fla. , Jan. 15, 2014  In an unprecedented effort to ... TB in ambulances and other transport vehicles, an advanced and portable ... rescue personnel for the first time. In order ... with these deadly pathogens, West Palm Beach ...
Breaking Medicine Technology:Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 2Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 3Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 2Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 3Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 4Superbugs No Longer Ride In Rescue Vehicles 2
... VIEJO, Calif., Oct. 12, 2011 Avanir Pharmaceuticals, Inc. ... affect (PBA) prevalence data from stroke survivors will be ... Congress of Rehabilitation Medicine/American Society for Neurorehabilitation Medicine in ... details about the data presentation at ACRM/ASNR Progress ...
... Good Start Genetics,™ Inc., an innovative molecular diagnostics ... screening, today announced that it will present results ... next-generation DNA sequencing platform at the Annual Meeting ...  ASRM will be held from October 15-19, 2011 ...
Cached Medicine Technology:Avanir Pharmaceuticals to Present Data at the 2011 American Congress of Rehabilitation Medicine/American Society for Neurorehabilitation Medicine Annual Conference 2Good Start Genetics to Announce Validation Study Results for its Next-Generation DNA Sequencing Platform During an Oral Presentation at the 2011 Annual Meeting of the American Society for Reproductive Medicine (ASRM) 2
(Date:4/23/2014)... Center researchers say clinical trials for a new ... are very promising. Patients treated with CPX-351, a ... are showing better responses than patients treated with ... "Acute myeloid leukemia is an aggressive blood cancer ... in older patients," explained Jeffrey Lancet, M.D., senior ...
(Date:4/23/2014)... to high-energy particles, simulating conditions astronauts would face on ... and slower reaction times, even when the radiation exposure ... impairments which affected a large subset, but far ... linked to protein changes in the brain, the scientists ... humans, suggest it may be possible to develop a ...
(Date:4/23/2014)... falls below normal levels are more likely to have ... disease and type 2 diabetes. A new simple screening ... and possible treatment is described in an article in ... from Mary Ann Liebert, Inc., publishers. The article is ... website at http://www.liebertpub.com/jmh . , ...
(Date:4/23/2014)... often displayed in the popular Swedish children,s TV ... high-sugar foods. A new study from the University ... children,s TV programmes as well as the link ... weight status. , Steingerdur Olafsdottir,s doctoral thesis focuses ... Swedish children,s TV show Bolibompa. Healthy foods dominated ...
(Date:4/23/2014)... of Midlife Occupational and Leisure Time Physical Activity on ... activity in midlife increases the risk of mobility limitation ... risk. This is found in a study which followed ... study was conducted at the Gerontology Research Center in ... Heavy physical labor is often repetitive, wears the body ...
Breaking Medicine News(10 mins):Health News:Moffitt Cancer Center's phase 3 study may be game-changer for acute myeloid leukemia 2Health News:Some astronauts at risk for cognitive impairment, animal studies suggest 2Health News:Some astronauts at risk for cognitive impairment, animal studies suggest 3Health News:High-calorie and low-nutrient foods in kids' TV 2Health News:Midlife occupational and leisure-time physical activity limits mobility in old age 2
... half their concerns, so doctors should listen carefully, ... -- Older patients and surgeons don,t communicate effectively ... decision to have surgery can be particularly difficult ... School of Medicine study. , The researchers recorded ...
... Air-Pulse Autonomic Meditation Therapy is a non-denominational therapy that allows ... identity many feel when adopting ancient mind controlling meditative healings. ... ... 14, 2008 –- Dr. Ajrawat,s http://www.painmanagement.com/ [Air-Pulse Autonomic ...
... childhood asthma, but, when compared to girls, they are also ... have a decreased incidence of asthma in the post-pubertal years. ... asthma development, according to a prospective study that analyzed airway ... moderate asthma over a period of about nine years. , ...
... the past two decades, medication errors have dramatically increased. DecisionHealth, ... potentially harmful medication errors. , ... Gaithersburg, MD (PRWEB) ... Health Ledger,s recent drug overdose, increased dramatically over the past two ...
... Investigators from the Melbourne Center of the international Ludwig Institute ... reported that they have developed a test to predict whether ... metastatic Stage IV cancer and death. , More than ... has spread to the lymph nodes will typically have ...
... Investment to Close in September, Subject to Stockholder ... Potential Launch of MOXATAG(TM), GERMANTOWN, Md., Aug. ... a pharmaceutical company focused on,developing and commercializing novel ... the quarter ended June 30,2008., MiddleBrook reported ...
Cached Medicine News:Health News:Older Adults Reluctant to Question Surgical Treatment 2Health News:Dr. Ajrawat's Air-Pulse Autonomic Meditation Therapy, a Revolutionary, Scientific, Meditation Therapy, Receives Patent Trademark 2Health News:Dr. Ajrawat's Air-Pulse Autonomic Meditation Therapy, a Revolutionary, Scientific, Meditation Therapy, Receives Patent Trademark 3Health News:Dr. Ajrawat's Air-Pulse Autonomic Meditation Therapy, a Revolutionary, Scientific, Meditation Therapy, Receives Patent Trademark 4Health News:Dr. Ajrawat's Air-Pulse Autonomic Meditation Therapy, a Revolutionary, Scientific, Meditation Therapy, Receives Patent Trademark 5Health News:Asthma in boys may be just a phase, but for girls it may be there to stay 2Health News:Fatalities From Medication Errors at Home Up Dramatically - DecisionHealth Offers Solutions 2Health News:Fatalities From Medication Errors at Home Up Dramatically - DecisionHealth Offers Solutions 3Health News:Prototype test for predicting clinical outcome for melanoma patients 2Health News:Prototype test for predicting clinical outcome for melanoma patients 3Health News:MiddleBrook Pharmaceuticals Reports Second Quarter 2008 Results 2Health News:MiddleBrook Pharmaceuticals Reports Second Quarter 2008 Results 3Health News:MiddleBrook Pharmaceuticals Reports Second Quarter 2008 Results 4Health News:MiddleBrook Pharmaceuticals Reports Second Quarter 2008 Results 5Health News:MiddleBrook Pharmaceuticals Reports Second Quarter 2008 Results 6Health News:MiddleBrook Pharmaceuticals Reports Second Quarter 2008 Results 7Health News:MiddleBrook Pharmaceuticals Reports Second Quarter 2008 Results 8Health News:MiddleBrook Pharmaceuticals Reports Second Quarter 2008 Results 9Health News:MiddleBrook Pharmaceuticals Reports Second Quarter 2008 Results 10Health News:MiddleBrook Pharmaceuticals Reports Second Quarter 2008 Results 11Health News:MiddleBrook Pharmaceuticals Reports Second Quarter 2008 Results 12Health News:MiddleBrook Pharmaceuticals Reports Second Quarter 2008 Results 13
Infusion Cannula, 2.0mm....
Subretinal Fluid Cannula, Curved; 20g (0.90) x 1-1/2" (38mm); 12mm Flexible Tubing Extends 6mm Beyond Tip; Curved at 65°....
Micro Vitreoretinal Cannula; Angled; 20g (0.90) x 1" (25mm); Tip Extension: 3mm, 32g (0.23); Angled at 65°, 1mm from Tip....
...
Medicine Products: