Navigation Links
Shire Completes Submission of NDA for Velaglucerase Alfa for Type 1 Gaucher Disease and Reports Positive Results for Remaining Two Phase III Trials
Date:9/1/2009

patients, is especially useful. I believe velaglucerase alfa will be an important new treatment option for Type 1 Gaucher disease and I am pleased that there is a mechanism in place for physicians to access this therapy for their patients."

Velaglucerase alfa is made using Shire's proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid sequence and has a human glycosylation pattern.

Phase III Studies Overview and Results

All three Phase III studies of velaglucerase alfa demonstrated positive results. The product was generally well-tolerated in both treatment naive and previously treated Gaucher patients. The three studies included: Study 032, which studied velaglucerase alfa in naive patients; Study 039, which was a head-to-head study of velaglucerase alfa and imiglucerase; and Study 034, which was a switch study from imiglucerase to velaglucerase alfa.

As reported on August 3, 2009, Study 032 in naive patients met its primary endpoint which evaluated change in hemoglobin concentrations from baseline. The top-line data press release can be found on: http://www.shire.com.

Study 039 was a 9-month, randomized, double-blind efficacy study in 34 treatment naive patients aged two years and older that compared velaglucerase alfa to imiglucerase. Patients were eligible to participate in the study if they presented with disease-related anemia and had at least one of the following clinical manifestations of Gaucher disease: thrombocytopenia, moderate splenomegaly or a readily palpable enlarged liver. Patients were randomized to receive either velaglucerase alfa or imiglucerase at 60 U/ kg every other week. The primary endpoint was the comparison of increases in hemoglobin concentrations between the velaglucerase alfa and imiglucerase groups. Secondary endpoints were com
'/>"/>

SOURCE Shire Plc
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA
2. Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease
3. Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
4. Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week
5. Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms
6. Shire Withdraws European Application for DAYTRANA(TM) (Methylphenidate Transdermal System)
7. Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent
8. Shire Announces Approval of ELAPRASE(R) (idursulfase) in Brazil
9. Shires Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose
10. Shire to Present Additional Scientific Data on ADHD Treatment Portfolio at American Psychiatric Association Annual Meeting
11. Shire Enhances its Orphan Drug Pipeline With the Acquisition of a New Clinical Candidate for Metachromatic Leukodystrophy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... Inc. (NASDAQ: UPI ), a medical device company ... treat voiding dysfunctions, today reported financial results for the ... Global revenue for the Company,s Urgent ®  PC Neuromodulation ... revenue record, as compared to $3.9 million in the ...
(Date:1/22/2015)... Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO), ("Pivotal" or the "Company"), a specialty ... disease and overall health is pleased to provide you with ... outlook for 2015 from the CEO, Mr. Eugene Bortoluzzi ... like to take this opportunity to share with you the ...
(Date:1/22/2015)... (NASDAQ: TECH ) announced today that it ... Simple Plex platform through its Proteins Platform division under ... the previously acquired CyPlex instrument platform from CyVek. ... technology which integrates an innovatively designed microfluidic cartridge with ...
Breaking Medicine Technology:Uroplasty Reports Record Revenue in Fiscal Third Quarter 2Uroplasty Reports Record Revenue in Fiscal Third Quarter 3Uroplasty Reports Record Revenue in Fiscal Third Quarter 4Uroplasty Reports Record Revenue in Fiscal Third Quarter 5Uroplasty Reports Record Revenue in Fiscal Third Quarter 6Uroplasty Reports Record Revenue in Fiscal Third Quarter 7Uroplasty Reports Record Revenue in Fiscal Third Quarter 8Uroplasty Reports Record Revenue in Fiscal Third Quarter 9Uroplasty Reports Record Revenue in Fiscal Third Quarter 10Uroplasty Reports Record Revenue in Fiscal Third Quarter 11Uroplasty Reports Record Revenue in Fiscal Third Quarter 12Uroplasty Reports Record Revenue in Fiscal Third Quarter 13Uroplasty Reports Record Revenue in Fiscal Third Quarter 14Uroplasty Reports Record Revenue in Fiscal Third Quarter 15Uroplasty Reports Record Revenue in Fiscal Third Quarter 16Uroplasty Reports Record Revenue in Fiscal Third Quarter 17Uroplasty Reports Record Revenue in Fiscal Third Quarter 18Pivotal Therapeutics: Year in Review and CEO Update 2Pivotal Therapeutics: Year in Review and CEO Update 3Pivotal Therapeutics: Year in Review and CEO Update 4Pivotal Therapeutics: Year in Review and CEO Update 5Pivotal Therapeutics: Year in Review and CEO Update 6Pivotal Therapeutics: Year in Review and CEO Update 7Bio-Techne Launches Simple Plex Platform 2Bio-Techne Launches Simple Plex Platform 3
... SAN DIEGO, March 21, 2011 Marshall Edwards, Inc.(Nasdaq: ... the clinical development of novel therapeutics targeting cancer metabolism, ... II clinical trial of intravenous Phenoxodiol in combination with ... is now available on the International Journal of ...
... 2011 CCS Medical today announced that its Board of ... for CCS Medical effective immediately.  Mr. Allison has been the ... "I am very excited about joining CCS Medical as its ... ourselves well in our markets and I look forward to ...
Cached Medicine Technology:Marshall Edwards Announces Publication of Phase II Clinical Trial Results Highlighting Activity of Intravenous Phenoxodiol 2Marshall Edwards Announces Publication of Phase II Clinical Trial Results Highlighting Activity of Intravenous Phenoxodiol 3
(Date:1/22/2015)... For over 20 years, Dr. David Cruz of ... area has treated just about every type of injury that ... And for those same twenty-plus years, the team at Doctors ... with the best possible doctor. With the combined breadth ...
(Date:1/22/2015)... Joan Lunden, award-winning American journalist, beloved television host, ... 32nd Annual Miami Breast Cancer Conference planned and ... , shares that “a fast-growing, virulent” cancer in her ... not followed up her clean mammogram with an ultrasound. ...
(Date:1/22/2015)... January 22, 2015 Yesterday, Senator ... (D-Concord) and Kristin Olsen (R-Modesto) were honored by ... in advancing biotechnology, biomedical science, medical device and ... each received the “2014 Life Sciences Champion” award ...
(Date:1/22/2015)... 2015 IsoComforter, Inc. has introduced the most ... IsoTube design to treat specific body parts and muscle groups. ... and easy to use patented cold therapy machine with the ... orthopedic and muscle injuries. IsoComforter has become the industry ...
(Date:1/22/2015)... 2015 Payday lending practices in four ... cause financial distress to the states that permit them, ... University’s Center on Race and Wealth. , While they ... payday loans at the same time substantially depress economic ...
Breaking Medicine News(10 mins):Health News:Industry Leading Chiropractor in Oceanside Joins the Doctors on Liens Network 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 5Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 6Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:IsoComforter Introduces Best of Class Cold Therapy Product to the Worldwide Market 2Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2
... found that the chance of successfully quitting can be ... their stay, and then have at least one month ... in to hospital provides an opportunity to stop smoking. ... has to stop temporarily while in hospital. People who ...
... What's billed as the world's biggest condom - a huge ... above a Dutch festival to increase safe sex awareness . ... Guinness Book of records - was commissioned by seven local ... Cross Festival in Lichtenvoorde, a small town near Almelo in ...
... the level of birth registration in certain parts of India ... year, 10 million still go unregistered . ,Two out ... not exist for government planning purposes, Plan India, a non-governmental ... deaths was made compulsory under the Registration of Births & ...
... people are unwilling or unable to stop smoking, but are ... smoke each day . ,After studying healthcare literature, ... reports that assessed methods aimed at helping people reduce use. ... cigarettes delivers clear health benefits. ,The main effort in ...
... death when seated, and not only when they are lying down, ... Childhood , a British journal. ,The findings are based ... among infants up to the age of 12 months in Quebec, ... deaths, 17, or 3.3 percent, occurred in babies who had been ...
... of extremes, boasts of almost a thousand no-sex-till-marriage organizations. ... Its brand ambassador beautiful teen Jami Waite, has been ... has risen from a single operation in Longview, Texas, ... can be abstinent, and its not weird, Waite declares. ...
Cached Medicine News:Health News:Hospital Provides an Oppurtunity to Quit Smoking 2Health News:Millions of Births Still Go Unreported in India 2Health News:Reducing Smoking - Mixed Messages and Latest Findings 2Health News:Virginity Rules-Meant To Be Broken? 2Health News:Virginity Rules-Meant To Be Broken? 3
... offers all of the benefits and ... with the additional feature of being ... imaging scanner for importing and storage ... or images. This additional feature allows ...
Inquire...
... Normal and Hypergamma Controls are ... either agarose gels or Sebia's ... Our unique control manufacturing process ... the other serum components, presenting ...
... Sebia's semi-automated agarose gel electrophoresis ... many tedious steps involved in classic ... system carries out all phases of ... migration to incubation to staining, destaining ...
Medicine Products: