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

CAMBRIDGE, Massachusetts, September 1 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today reported that it has completed its submission of a New Drug Application (NDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease, with the U.S. Food and Drug Administration (FDA). The Company also announced positive results from the final two Phase III studies of velaglucerase alfa, with both studies reaching all of their primary and secondary endpoints.

"The submission of the NDA for velaglucerase alfa, earlier than previously announced, is an important milestone for Shire, bringing us another step closer to providing a new treatment option for patients with Type 1 Gaucher disease," said Sylvie Gregoire, President of Shire Human Genetic Therapies. "We are also pleased to report that the data from our final two Phase III trials met our expectations by reaching all of their primary and secondary endpoints, demonstrating consistency with the results recently reported from the first Phase III trial. In addition, we are on-track to submit our European filing for velaglucerase alfa by the end of 2009."

Shire's velaglucerase alfa program included the largest and most comprehensive set of Phase III clinical trials conducted to date for Gaucher disease. Over 100 patients at 24 sites in 10 countries around the world have participated in the clinical studies.

"I am impressed by the series of clinical trials that were designed to evaluate velaglucerase alfa at multiple doses and in different patient groups," said Dr. Christine Eng, Professor of Molecular and Human Genetics, Baylor College of Medicine. "The inclusion of children, who are often the sickest
'/>"/>

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:10/20/2014)... , Oct. 20, 2014  PneumRx, Inc. ( ... pulmonology, today announced completion of enrollment in their RENEW ... Clinical Study is the FDA-approved IDE pivotal trial for ... emphysema. It was anticipated that the study, ... 2013, would take until the end of 2014 to ...
(Date:10/20/2014)... , 20 de octubre de 2014  PneumRx, ... campo de la pulmonología intervencional, anunció hoy la ... casi 3 meses antes de lo programado. El Estudio ... de dispositivo de investigación (IDE) aprobada por la ... sistema de espiral de reducción de volumen pulmonar ...
(Date:10/20/2014)... , Oct. 20, 2014  Indianapolis interventional ... Toronto -based 3D visualization leader ... Congress of Neurological Surgeons Annual Meeting that they ... for brain surgery. The collaboration is the first ... combination to improve patient outcomes. NICO,s BrainPath® interventional ...
Breaking Medicine Technology:PneumRx Completes RENEW Pivotal Trial Enrollment 2PneumRx Completes RENEW Pivotal Trial Enrollment 3PneumRx concluye inscripción en prueba fundamental RENEW 2PneumRx concluye inscripción en prueba fundamental RENEW 3Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 2Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 3Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 4Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 5
... in a physicians office practice, can be instrumental ... ailments; UTIs, diabetes, several cancers, metabolic disorders, cardiovascular ... for urinalysis tests is well in excess of ... For such a fundamental, extensive and economically significant ...
... large multi-site lab faced challenges with manual document ... were exacerbated by staff shortages and growing test ... was essential for accreditation compliance and also to ... manage documents. They therefore assessed a variety of ...
Cached Medicine Technology:Urinalysis Analyzers: Large Capabilities in Every Size Device 2Urinalysis Analyzers: Large Capabilities in Every Size Device 3Choosing Lab Quality Management Software 2Choosing Lab Quality Management Software 3Choosing Lab Quality Management Software 4
(Date:10/20/2014)... 20, 2014 The newly updated Worldwide ... of thousands of facts, figures and forecasts on the ... medical sector forecast categories the Worldwide Medical Market ... and national views on the worldwide medical market to ... report gives you data for 2010-2019, covering each country ...
(Date:10/20/2014)... October 20, 2014 With a mere ... Charlie Crist made a brief fundraising stop at the ... Thursday. , Fresh from a debate last night with ... the stage for the first seven minutes because Crist ... governor described the incident in one word: "weird." , ...
(Date:10/20/2014)... PA (PRWEB) October 20, 2014 Allegheny ... minimally-invasive procedure that enables physicians to repair a damaged ... The MitraClip system, developed by Abbott ... (MR), a progressive and life-threatening condition in which the ... blood to flow backward from the heart’s left ventricle ...
(Date:10/20/2014)... The Advocator Group, LLC ... American Foundation for Suicide Prevention’s (AFSP) Out of the ... not-for-profit organization that hosts hundreds of community walks throughout ... are used to help understand and prevent suicide through ... as well. , The Advocator Group shares this ...
(Date:10/20/2014)... NY (PRWEB) October 20, 2014 ... non-profit organization that helps New Yorkers living with ... changes toward health, housing, recovery and self-sufficiency. Each ... transformed the local community through their tireless efforts. ... Marc Shapses , has been selected as ...
Breaking Medicine News(10 mins):Health News:Worldwide Medical Market Forecasts to 2019 a New Research Report Added to ReportsnReports.com 2Health News:Worldwide Medical Market Forecasts to 2019 a New Research Report Added to ReportsnReports.com 3Health News:Worldwide Medical Market Forecasts to 2019 a New Research Report Added to ReportsnReports.com 4Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 2Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 3Health News:Allegheny General Hospital Introduces New, Beating-Heart Procedure for Mitral Valve Repair 2Health News:Allegheny General Hospital Introduces New, Beating-Heart Procedure for Mitral Valve Repair 3Health News:The Advocator Group, LLC is Proud to Participate in an Out of the Darkness Community Walk, October 25th, to Increase Suicide Awareness 2Health News:The Advocator Group, LLC is Proud to Participate in an Out of the Darkness Community Walk, October 25th, to Increase Suicide Awareness 3Health News:Savills Studley's Marc Shapses To Be Honored as 2014 "Positive Changemaker" by ASCNYC 2Health News:Savills Studley's Marc Shapses To Be Honored as 2014 "Positive Changemaker" by ASCNYC 3
... impurities in the chocolate? Have the plastic seams been ... parcel? Answers to all these questions are provided by ... millimeter-wave sensor is able to see through all non-transparent ... Physics and Radar Techniques FHR in Wachtberg have developed ...
... Reporter , TUESDAY, Dec. 20 (HealthDay News) -- Sleep problems ... health issues and poorer performance on the job, a new ... from the United States and Canada online or in person ... disorder. The most common problem, suffered by one-third of ...
... -- Starting aquatic therapy within days after total knee replacement ... for those who,ve had a total hip replacement, according to ... knee and hip replacements is increasing, but there is a ... noted the German researchers. Aquatic therapy has been shown ...
... BRUNSWICK, N.J. Despite improvements to diagnostic tools and ... the diagnosis and treatment of depression remain, according ... Journal of Public Health ; print, February 2012. ... Care in Community-Dwelling Elderly in the United States," lead ...
... News) -- Precautionary measures need to be used in ... sudden death related to overexertion and exhaustion, researchers say. ... due to sickle cell trait during a workout, the ... athletes. University of Michigan researchers evaluated the effect ...
... TUESDAY, Dec. 20 (HealthDay News) -- More Americans now die ... new government report released Tuesday. In 2008, poisoning deaths ... United States and the leading cause of injury death in ... for Disease Control and Prevention. Ninety percent of these ...
Cached Medicine News:Health News:Monitoring food with millimeter waves 2Health News:Many Police Officers Battle Sleep Woes, Study Finds 2Health News:Many Police Officers Battle Sleep Woes, Study Finds 3Health News:Timing of Aquatic Therapy After Joint Replacement Matters 2Health News:Diagnosis, treatment of depression among elderly depend on racial, cultural factors 2Health News:Diagnosis, treatment of depression among elderly depend on racial, cultural factors 3Health News:Screening Alone Not Enough to Prevent Sudden Death in College Athletes 2Health News:Drug Overdoses Kill More Americans Than Car Accidents: CDC 2Health News:Drug Overdoses Kill More Americans Than Car Accidents: CDC 3
ACMI™ offers an assortment of fiberoptic light guides, high transmission autoclavable fiberoptic light guides, and light guide adapters to connect our scopes to other manufacturers' light sourc...
ACMI™ offers an assortment of fiberoptic light guides, high transmission autoclavable fiberoptic light guides, and light guide adapters to connect our scopes to other manufacturers' light sourc...
ACMI™ offers an assortment of fiberoptic light guides, high transmission autoclavable fiberoptic light guides, and light guide adapters to connect our scopes to other manufacturers' light sourc...
... lineup of high-powered Xenon, Metal Halide ... brightness in a durable, lightweight design. ... quality light guide cables, providing optimal ... durable design., Extraordinarily compact yet offering ...
Medicine Products: