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

or the long-term clinical efficacy and safety of velaglucerase alfa," said Pramod Mistry, MD, PhD, FRCP, Professor of Pediatrics & Internal Medicine at Yale University School of Medicine. "The Gaucher community is very fortunate to have velaglucerase alfa as an option for patients."

Results from Study TKT032 in Adults and Children

TKT032 was a 12-month, randomized, double-blind, parallel-group global study in 25 treatment-naive patients aged two years and older that evaluated velaglucerase alfa at 45 U/kg and velaglucerase alfa at 60 U/kg. 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.

The primary endpoint was change in hemoglobin concentrations from baseline at 60 U/kg. Secondary endpoints for both doses were changes in platelet counts, changes in organ volumes, changes in surrogate markers of Gaucher disease, and for the 45 U/kg dose only, change in hemoglobin concentrations from baseline.

At 12 months, in the 60 U/kg group, statistically significant changes in mean hemoglobin concentration increased 23.3%, +2.43+/-0.32 g/dL, P< 0.0001; mean platelet count increased 65.9%, +50.9+/-12.2x10(9)/L, P=0.0016; and mean spleen volume decreased 50%, -1.92+/-0.51% body weight, P=0.0032, from 14.0 multiples of normal [MN] at baseline to 5.75 MN. Mean liver volume decreased 17%, -0.84+/-0.33% body weight, P=0.0282, from 1.46 to 1.22 MN.

Results for 45 U/kg were consistent with those observed with 60 U/kg; however a dose-related effect in favor of velaglucerase alfa at 60 U/kg was observed by platelet count increase and liver volume reduction between the 2 dose groups.

Adverse events
'/>"/>

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:12/19/2014)... CARDIFF-BY-THE-SEA, Calif. , Dec. 19, 2014 ... ;  Sorrento), an oncology company developing new treatments ... a privately-held immuno-oncology company developing proprietary Neukoplast ® ... therapy, announced today that the companies have entered ... generation CAR-TNK™ (pronounced as "Car-Tank") immunotherapies for the ...
(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)... CITY, Kan. , Dec. 18, 2014 /PRNewswire/ ... PETX ), a biopharmaceutical company focused on the ... companion animals, today announced positive results from its ... innovative drug for treating pain in dogs with ... improvements in pain assessment scores that were statistically ...
Breaking Medicine Technology:Sorrento and Conkwest Announce Exclusive Global Collaboration 2Sorrento and Conkwest Announce Exclusive Global Collaboration 3Sorrento and Conkwest Announce Exclusive Global Collaboration 4Sorrento and Conkwest Announce Exclusive Global Collaboration 5U.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 3Aratana Therapeutics Announces Positive Top-Line Results from AT-001 Pivotal Field Study in Client-Owned Dogs with Osteoarthritis 2Aratana Therapeutics Announces Positive Top-Line Results from AT-001 Pivotal Field Study in Client-Owned Dogs with Osteoarthritis 3Aratana Therapeutics Announces Positive Top-Line Results from AT-001 Pivotal Field Study in Client-Owned Dogs with Osteoarthritis 4Aratana Therapeutics Announces Positive Top-Line Results from AT-001 Pivotal Field Study in Client-Owned Dogs with Osteoarthritis 5
... Inc. (Soligenix or the Company) (OTC BB: SNGX), a ... its North American licensing partnership with Sigma - Tau ... commercialization of orBec® (oral beclomethasone dipropionate or Oral BDP) ... the amended agreement, Sigma - Tau has made a ...
... SAN DIEGO, July 28, 2011 Cardium Therapeutics (NYSE Amex: ... plan to acquire substantially all of Transdel Pharmaceuticals, business assets ... of the U.S. Bankruptcy Code. As described on June 27, ... to a number of conditions, including approval of the bankruptcy ...
Cached Medicine Technology:Soligenix Announces Expansion of Partnership With Sigma-Tau Pharmaceuticals for orBec® in Europe 2Soligenix Announces Expansion of Partnership With Sigma-Tau Pharmaceuticals for orBec® in Europe 3Soligenix Announces Expansion of Partnership With Sigma-Tau Pharmaceuticals for orBec® in Europe 4Soligenix Announces Expansion of Partnership With Sigma-Tau Pharmaceuticals for orBec® in Europe 5Soligenix Announces Expansion of Partnership With Sigma-Tau Pharmaceuticals for orBec® in Europe 6Soligenix Announces Expansion of Partnership With Sigma-Tau Pharmaceuticals for orBec® in Europe 7Soligenix Announces Expansion of Partnership With Sigma-Tau Pharmaceuticals for orBec® in Europe 8Cardium Reports on Transdel Transaction 2Cardium Reports on Transdel Transaction 3Cardium Reports on Transdel Transaction 4
(Date:12/20/2014)... LunaDress has recently announced its 2015 collection of ... on all of its special occasion dresses & wedding apparel. ... wedding gown. If you have no idea of what to ... different wedding dress styles and our dress experts are here ... current special offer, up to 80% off," the CEO of ...
(Date:12/20/2014)... The print component of Healthy Aging is distributed ... 160,000 copies and an estimated readership of 420,000. The ... media strategy and across a network of top news ... of the campaign, click here . , The ... of CTV’s The Social. Lainey Lui, Melissa Grelo, ...
(Date:12/20/2014)... Recently, VogueQueen.com, a leading wedding dress ... Sale Online for 2015. Great discounts are now ... old consumers can get a discount, up to 80% ... website before January 30, 2015. , VogueQueen.com has recently ... a prom dress promotion. Many customers worldwide like VogueQueen’s ...
(Date:12/20/2014)... December 20, 2014 Angeldress.co.uk, the distinguished ... great for worldwide dress fans. The company has recently ... and information. For the holiday season, Angeldress Blog ... special wedding apparel. , Angeldress.co.uk prides itself in offering ... level of service. All the company’s outfits are very ...
(Date:12/20/2014)... 20, 2014 Atore, Inc, (San Francisco, ... launched first birthday focused portal on December 17th, 2014. ... launched in both US and Japan. , MERRY BIRTHDAY ... http://merrybirthday.net/message/ , MERRY BIRTHDAY MESSAGE is part ... the world. , Features, Choose from thousands of stock ...
Breaking Medicine News(10 mins):Health News:2015 Collection of Wedding Dresses from LunaDress Online on Sale Now 2Health News:The ladies of The Social urge Canadian women to put themselves first over the holiday season and into the new year in Mediaplanet’s “Women’s Health” campaign 2Health News:VogueQueen Big Sale Online For The Coming 2015 2Health News:Trendy Professional Wedding Apparel Recommended by Angeldress Blog 2Health News:Atore, Inc. Releasing the First Birthday Portal 2
... ... IBM ) today announced that its lending arm, IBM Global ... healthcare records (EHR) providers, highlighting the growing need for private financing ... face to adopt health IT solutions. , (Logo: http://www.newscom.com/cgi-bin/prnh/20090416/IBMLOGO ...
... , RANCHO SANTA FE, Calif., Dec. 22 ... checking them twice, Helen Woodward Animal Center (HWAC) began a quest ... Puerto Rico,s Canita Animal Sanctuary the HWAC team from Rancho Santa ... the largest Humane Society facility on the island only three of ...
... , ... 22 /PRNewswire-Asia/ -- Avery Dennison Specialty Tape has,developed a proprietary ... Its newest generation of ultra-thin hydrocolloid,adhesives delivers real consumer benefits ... skin softening beneath the dressing, and,gentle removal. , ...
... ... effective in the alleviation of symptoms associated with many chronic conditions such as allergies, ... 300 practices throughout the country are using this holistic therapy including over 50 branded ... ...
... Make your New ... for 2010. So says Australian weight loss and dieting researcher, Mr Trevor Johnson. With an epidemic ... new year,s weight loss resolutions fail within the first week. The primary cause of the failure ... (PRWEB) ...
... study published in the January issue of Radiology , ... MRI declined to undergo the procedure. "Given that ... early breast cancer, we were surprised that barely half of ... even when offered at no cost," said Wendie A. Berg, ...
Cached Medicine News:Health News:IBM Financing Agreements With Electronic Healthcare Record Providers Shatter Barriers To Health IT Adoption 2Health News:IBM Financing Agreements With Electronic Healthcare Record Providers Shatter Barriers To Health IT Adoption 3Health News:IBM Financing Agreements With Electronic Healthcare Record Providers Shatter Barriers To Health IT Adoption 4Health News:IBM Financing Agreements With Electronic Healthcare Record Providers Shatter Barriers To Health IT Adoption 5Health News:While Some Were Counting Sugar Plums...Others Were Changing the Future 2Health News:Avery Dennison Innovates in Consumer Wound Care 2Health News:Avery Dennison Innovates in Consumer Wound Care 3Health News:BioVeda Health and Wellness Center of Nampa, ID Announces its Grand Opening 2Health News:BioVeda Health and Wellness Center of Nampa, ID Announces its Grand Opening 3Health News:BioVeda Health and Wellness Center of Nampa, ID Announces its Grand Opening 4Health News:BioVeda Health and Wellness Center of Nampa, ID Announces its Grand Opening 5Health News:Making New Year's Resolution Today is Key to 2010 Weight Loss & Dieting Success 2Health News:Elevated-risk women refuse MRI breast cancer screening 2
... DBM Matrix PLF is ... material designed specifically for ... trough-like design allows for ... bone. Demineralized bone fibers ...
Demineralized bone matrix dispensed in a syringe. DBM will be free of foreign matter. Demineralized bone matrix particle size 125 to 850 . Glycerol 70-88% by weight. Calcium content less than 8%....
... Olympus' new generation Endoalpha is a centralized ... surgeon and the nurse by giving them ... Endoalpha provides protection against obsolescence, as future ... than the purchase of an entirely new ...
... systems two-piece design provides maximum positioning flexibility while ... for safe storage and easy transport. The system ... of floor space, but at the same time ... sterile field. Both the camera and display of ...
Medicine Products: