Navigation Links
Amsterdam Molecular Therapeutics Receives Opinion on Glybera(R) Marketing Authorisation Application
Date:6/23/2011

AMSTERDAM, June 24, 2011 /PRNewswire/ --


 

- Dossier Re-Examination Process Initiated

Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, today announced that it has received an opinion on its Marketing Authorisation Application (MAA) for Glybera® (alipogene tiparvovec) as a potential therapy for Lipoprotein Lipase Deficiency ("LPLD"). Following a recent meeting with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), AMT has been notified that, at this time, Glybera is not approvable.

Subsequent to a review of the CHMP's letter, AMT believes that Glybera can receive a positive opinion subject to generating additional data from existing patients. AMT has therefore decided to ask for a re-examination of the clinical data package.

"From what we know today, despite the disappointment, we believe that there is an indication from the CHMP that Glybera could receive approval and that the current opinion at this time is a reflection of insufficient proof of clinical benefit of Glybera as a result of low patient numbers measured for chylomicron handling for at least 12 months post treatment. The CHMP also indicated that if certain additional data from already treated patients would confirm current results by the end of 2011, an approval may be possible," noted Jörn Aldag, CEO of AMT. "In the dossier, we provided important data showing Glybera is safe and prevents episodes of pancreatitis, the major clinical complication of LPLD. We appreciate the CHMP's responsibility for caution on such an advanced therapy, so we will work diligently to generate more information and, we hope, ensure that Glybera will still reach patients."

Next steps

As part of the MAA, AMT presented data to the CHMP on Glybera showing evidence in reducing the risk of pancreatitis. Also, the company demonstrated a clear signal of patients' ability to b
'/>"/>

SOURCE Amsterdam Molecular Therapeutics B.V
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Pharma and Food Thought Leaders Set to Converge in Amsterdam Next April 2011
2. Amsterdam Molecular Therapeutics Reports Promising Data From Cholesterol Lowering Gene Therapy Study
3. PharmacoFore, Inc. Announces Positive Results from a Phase I Clinical Study of Its Hydromorphone Bio-Activated Molecular Delivery™ System, and Upcoming Presentation at the 2011 BIO Business Forum During the Annual BIO International Convention in Was
4. Latest Molecular Diagnostics Technology Aids German Hospital in Management of European E. coli Crisis
5. Data from Clinical Studies of bioTheranostics CancerTYPE ID® and Breast Cancer Index(SM) Molecular Diagnostic Tests Presented at ASCO 2011 Annual Meeting
6. ImaginAb, Inc. Announces Availability of Custom Protein Radiolabeling Services for Molecular Imaging
7. Medco Partners With MolecularMD on Personalized Medicine Program for Chronic Myeloid Leukemia
8. The World Leader in Molecular Breast Imaging to Premiere Largest Detector in the Industry
9. Gen-Probe Files for US Regulatory Clearance of PANTHER™ System, Fully Automated and Integrated Molecular Testing Instrument
10. Latest Clinical Evidence Supports Promising Outlook for Low-Dose Molecular Breast Imaging (MBI)
11. Cepheid Extends Rapid Molecular Diagnostics Leadership with FDA Clearance of Xpert Clostridium difficile/Epi
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2014)... LOS ANGELES , July 24, 2014 /PRNewswire/ ... medical devices, announced today that after two weeks ... experts throughout the European Union, it gained substantial ... (sub-epidermal moisture) and the clinical utility of BBI,s ... surveys, over 90 percent of the respondents drawn ...
(Date:7/24/2014)... WHIPPANY, N.J. , July 24, 2014 /PRNewswire-USNewswire/ ... Phase III trial that evaluated a 15% foam ... the topical treatment of inflammatory papules and pustules ... potential treatment option to complement the currently available ... disease causing inflammatory lesions (papules and pustules) as ...
(Date:7/24/2014)... , July 24, 2014  Market Diagnostics International ... IVD Insights™ LabFile , a data resource that ... clinical laboratory universe and identifying target In Vitro ... proprietary database that provides IVD manufacturers with accurate ... relying on clear and consistent definitions of laboratory ...
Breaking Medicine Technology:Bruin Biometrics Secures Support of EU Scientific Community for its SEM Scanner Technology 2Phase III Investigational Trial of Azelaic Acid 15% Foam Meets Both Co-Primary Endpoints in Subjects with Papulopustular Rosacea 2Phase III Investigational Trial of Azelaic Acid 15% Foam Meets Both Co-Primary Endpoints in Subjects with Papulopustular Rosacea 3MDxI Launches Data Resource Setting New Standard for Defining and Targeting US Clinical Laboratory Universe 2
... Va., June 22 With today,s announcement that the Pharmaceutical ... grant some $80 billion in discounts to Medicare beneficiaries over ... costs, the Healthcare Compliance Packaging Council (HCPC) noted that far ... to help people take their prescription drugs properly. ...
... /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE ... that a new corporate presentation is available for review ... . The presentation includes information on ... treat swine and other influenza viruses using its L.E.A.P.S.(TM) ...
Cached Medicine Technology:HCPC Calls for Greater Healthcare Savings Through Improved Adherence to Prescription Drug Regimens 2HCPC Calls for Greater Healthcare Savings Through Improved Adherence to Prescription Drug Regimens 3
(Date:7/24/2014)... 2014 National Analysts Worldwide, the Philadelphia-headquartered ... will operate globally under the name, NAXION , ... Employee Stock Ownership Plan (ESOP) organization led by majority ... . The firm guides market strategy in target ... , Said McDonald, “We wanted our name to better ...
(Date:7/24/2014)... The report, “Feed Palatability Enhancers & ... (Swine, Poultry, Cattle, Pets, Aquaculture, and Others) - Global ... feed palatability enhancers & modifiers market with an analysis ... value, of types of feed flavors, sweeteners, and text ... figures spread through 275 pages and in-depth TOC on ...
(Date:7/24/2014)... and faster, according to a new study published in ... to tackle melanoma, the most deadly form of skin ... of Manchester found that some melanoma cells are particularly ... surrounding tissue, while other melanoma cells are the opposite ... tumour, the faster growing cells ,piggy-back, along with the ...
(Date:7/24/2014)... The Biofeedback Federation of ... distribution agreement with game development company Zukor Interactive. ... groups to offer Zukor's Grind , a ... neurofeedback in European and international markets. , Zukor's ... to be used as a biofeedback/neurofeedback training tool. ...
(Date:7/24/2014)... WEDNESDAY, July 23, 2014 (HealthDay News) -- Even though its ... best known as Tylenol -- does not help treat lower ... The researchers found the drug was no more effective than ... acute lower back pain. Besides showing no effect in ... help in improving sleep woes tied to back pain, nor ...
Breaking Medicine News(10 mins):Health News:National Analysts Worldwide Announces a Change of Name to NAXION 2Health News:National Analysts Worldwide Announces a Change of Name to NAXION 3Health News:Feed Palatability Enhancers & Modifiers Market Worth $3172.6 Million by 2019 - Report by MarketsandMarkets 2Health News:Feed Palatability Enhancers & Modifiers Market Worth $3172.6 Million by 2019 - Report by MarketsandMarkets 3Health News:Feed Palatability Enhancers & Modifiers Market Worth $3172.6 Million by 2019 - Report by MarketsandMarkets 4Health News:Piggy-backing cells hold clue to skin cancer growth 2Health News:Biofeedback Federation of Europe Enters Distribution Agreement with Zukor Interactive 2Health News:Biofeedback Federation of Europe Enters Distribution Agreement with Zukor Interactive 3Health News:Acetaminophen May Not Help Against Back Pain, Study Contends 2Health News:Acetaminophen May Not Help Against Back Pain, Study Contends 3
... ... year’s edition of The Leading Physicians of the World. With a long track record of ... of the World wanted to honor the specialty so integral to the surgical team; anesthesiology. ... (PRWEB) June 26, 2010 ...
... ... by whiplash injury should be made aware of their legal entitlement to file a whiplash ... ... leading whiplash injury claims lawyers, is today warning of the need for greater awareness of ...
... ... Haitian children, mostly refugees and orphans who go all day without eating. Shelene Bryan and ... ... and her Skip1 team of volunteers were deep inside Haiti and the Dominican Republic delivering ...
... ... a renewable resource. , ... June 26, 2010 -- Laser and copier toners use over 146,000,000 gallons of oil per ... or Forestry products, therefore, eliminating the need for petroleum products. The term bio-product is ...
... studying and treating disease and for the practice of ... the cells that may one day be transplanted into ... studies going on worldwide, scientists at the UCLA Broad ... X chromosome inactivation take place in very early passages ...
... By Maryann Mott HealthDay Reporter , FRIDAY, June ... chuckle out of watching their dog sleep while its paws race ... in dreamland, and scientists say they were right: Pets do ... of past events replay in their minds much the same way ...
Cached Medicine News:Health News:The International Association of Anesthesiologists Places its Top Doctors in the Renowned Medical Publication, The Leading Physicians of the World. 2Health News:The International Association of Anesthesiologists Places its Top Doctors in the Renowned Medical Publication, The Leading Physicians of the World. 3Health News:Whiplash Claims Warns on Awareness of Personal Injury Compensation Entitlement 2Health News:Shelene Bryan and Skip1.org Help Build Kitchen for Haitian Orphans 2Health News:Great Office Buys Announces the Addition of Elite Brand Bio-Based Toners to their Product Line 2Health News:Chromosomal variations found in early passage female embryonic stem cells 2Health News:Chromosomal variations found in early passage female embryonic stem cells 3Health News:Where Do Pets Go When They Dream? 2Health News:Where Do Pets Go When They Dream? 3
... heavy duty, controlled stretch knee support that ... allowing full range of motion. The ... the knee, and help to keep the ... This is an excellent support for ...
... breathable foam. Three piece design for precise ... loop closures. Lightweight rigid posterior stays with ... with optional hot and cold therapy Gel ... pain cycle by providing cold therapy to ...
... Scoring: , One of the outstanding features ... our patented Three-Dimensional Molding Technology. , This ... brace which effectively controls the bunching and ... comfort to the wearer. , ...
... new padding system from Innovation Sports. Exceptionally ... contours to the unique anatomy of each ... Gel Fit's proprietary Octogrip™ Anti-Slip System improves ... when the brace is strapped on. Gel ...
Medicine Products: