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:1/23/2015)... Jan. 23, 2015  Now available for sale, The Armor1 ... that prevents ankle sprains by cushioning the ankle from ... securely around the outside of any shoe type and ... while still offering protection against sprains. With customers in ...
(Date:1/23/2015)... SETAUKET, N.Y. , Jan. 23, 2015  Lixte Biotechnology Holdings, ... where its Phase I trial of Lixte,s lead compound, LB‑100, ... institutions. John S. Kovach , M.D., the ... was planned to be completed at a single site. Accrual ...
(Date:1/23/2015)... TOWN, South Africa , Jan. 23, 2015   ... distributor of personal protective equipment for all forms of ... the flagship Leatt-Brace® neck brace, announced today that the ... racing federation, now requires all riders to wear a ...
Breaking Medicine Technology:The Armor1 Ankle Roll Guard is the New Breakthrough Solution for Ankle Sprain Prevention! 2Lixte Biotechnology Holdings Announces Expansion Of Clinical Sites For Its Phase I Trial Of Its Lead Anti-Cancer Compound, LB-100 2Lixte Biotechnology Holdings Announces Expansion Of Clinical Sites For Its Phase I Trial Of Its Lead Anti-Cancer Compound, LB-100 3Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 2Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 3
(Date:1/22/2015)... LunaDress, with its top dressmaking technologies, has ... the business is showing its latest designs of wedding dresses ... to the company’s CEO, all the fresh new products are ... discounts, up to 80% off. All the clothes from LunaDress ...
(Date:1/22/2015)... VogueQueen is a seasoned and trusted leader who consistently ... thrilled to have it lead the wedding dress industry into ... prom dresses for the global market. , “The CEO of ... he focuses on continuing the goal of operational excellence and ...
(Date:1/22/2015)... 2015 The federal court overseeing thousands of ... Court, Southern District of West Virginia has upheld a $2 ... first bellwether trial. In an Order dated January 21st, the ... finding that C.R. Bard had not proven a miscarriage of ...
(Date:1/22/2015)... January 22, 2015 For over 20 years, Dr. ... Oceanside and Vista area has treated just about every type ... injury circumstances. And for those same twenty-plus years, the team ... all those injuries with the best possible doctor. With ...
(Date:1/22/2015)... 2015 Recently, Weddingshe.com has added many trendy ... announced its highest annual revenues in the past three years. ... glamorous wedding dresses. , According to the sales manager of ... promotions for them in 2015. This point can be reflected ...
Breaking Medicine News(10 mins):Health News:LunaDress Shows The Latest Styles Of Wedding Dresses In 2015 2Health News:VogueQueen Unveils New Designs of Prom Dresses for 2015 2Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 2Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 3Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 4Health News:Industry Leading Chiropractor in Oceanside Joins the Doctors on Liens Network 2Health News:Weddingshe Announces A Special Offer On Its Popular Glamorous Wedding Dresses 2
... lead to muscle spasms, fever, sweating and nausea, study ... commonly used migraine medication may cause so-called serotonin syndrome ... the May 15 issue of the New England ... the U.S. Food and Drug Administration detail 11 cases ...
... Professors Honored for Their Research -, PALO ... 12,outstanding Ph.D. students and two professors with the ... the field of organic,chemistry. The winners participated in ... perspective on the important role of organic,chemistry in ...
... 14 On Sunday, June 29,2008, West Coast Bank ... the Bridge Run, Portland,s most unique 8k personal,challenge run., ... must reach the,Burnside Bridge by 9:00 a.m. when the ... next to the Oregon Zoo and winds through the,paved ...
... of the International Association of Business Communicators has named ... Medical School at Houston, its Executive Communicator of the ... the organizations annual Bronze Quill Awards Banquet at the ... recipient of the award, which recognizes excellence in leadership ...
... ANGELES, May 14 SheKnows.com,( http://www.SheKnows.com ), ... women, announced today the acquisition of PregnancyandBaby.com,( ... women from,preconception through pregnancy., PregnancyandBaby is ... those who are pregnant or planning to ...
... NEW YORK, May 14 Two days after ... of its full impact on the,communities living close to ... speed., According to AFP news service, military aircraft ... air. The agency also reported,that a number of villages ...
Cached Medicine News:Health News:Migraine Medications May Cause 'Serotonin Syndrome' 2Health News:Migraine Medications May Cause 'Serotonin Syndrome' 3Health News:Roche Symposium Showcases Accomplishments of Next Generation of Chemists 2Health News:Roche Symposium Showcases Accomplishments of Next Generation of Chemists 3Health News:UT Houston Dean Colasurdo named Executive Communicator of the Year 2Health News:SheKnows Acquires PregnancyandBaby - Online Community From Preconception Through Birth 2Health News:UNICEF Rushing Medical Supplies, Tents, Clean Water to Children Affected by Powerful Earthquake in China 2
Velcro® Tracheostomy tube holders are available in Adult, pediatric, and infant sizes....
... patient will be more comfortable, and you ... stabilization more secure and to avoid the ... untying of twill ties, consider the Dale® ... neonate/infant sizes, the narrow fastener tabs of ...
... of use and patient comfort, our soft ... comfort and is available in a range ... fit. For hard to fit patients, MARPAC ... your specifications. Don't just take our word ...
... Keeps tracheostomy tube securely in place. ... One size fits all. Soft compliant foam ... and accommodates coughing and edema while still ... between collar and tube helps prevent sliding ...
Medicine Products: