Navigation Links
Tafamidis: Approval denotes proven added benefit
Date:9/17/2012

>Positive effect in neurological disorders only limited

Only one of the two relevant studies (Fx-005) provided reliable data - and only for patients with a particular genetic defect (Val30Met). The second study (Fx1A-201) in adults with different genetic defects was not controlled, i.e. here the effect of tafamidis was not directly compared with another treatment. It remains unclear how the results of the reliable study can be applied to the patients with genetic defects other than Val30Met.

Assessment of the study data according to the methods of IQWiG produced a hint of a positive effect of tafamidis in respect of the progression of nerve damage. However the effect was only minor.

With regard to other patient-relevant outcomes (other symptoms and side effects, mortality, quality of life), the Institute was unable to identify any further statistically significant advantages or disadvantages of tafamidis compared with the comparator treatment.

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessment conducted by the G-BA. After publication of the manufacturer's dossier and its assessment by IQWiG, the G-BA initiates a formal commenting procedure which provides further information and can result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.


'/>"/>

Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-221-356-850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

Page: 1 2

Related medicine news :

1. Tafamidis: Approval denotes proven added benefit
2. U.S. Bests Canada, Europe in Drug Approvals
3. Approval of Safer Alternative to Pradaxa Delayed by FDA
4. EP Global Communications, Inc. Achieves Shareholder Approval for Restructuring and Signs Definitive Restructuring Agreement
5. UW study plays pivotal role in todays FDA approval of HIV prevention drug
6. Cleveland Clinic Florida receives approval for transplant programs at Weston Facilities
7. Electronic Cigarettes Proven as One of the Most Effective Ways to Quit Smoking
8. Collagenase for Dupuytrens contracture: Added benefit not proven
9. New roadmap suggests proven routes to ending health disparities
10. Added benefit of linagliptin is not proven
11. Benefit of PET and PET/CT in ovarian cancer is not proven
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... at the University of Michigan have described a new ... fraction of the time needed for more traditional methods. ... novel antibody that is undergoing further investigation as a ... , In research published online in the ... researchers in the lab of Stephen Weiss at the ...
(Date:9/30/2014)... Fla. (PRWEB) September 30, 2014 Lea ... is giving breast cancer patients a new, more practical ... , Women who undergo mastectomies, biopsies and lumpectomy surgeries ... promote healing. But after seeing her patients describe the ... compelled to create a new bra in her spare ...
(Date:9/30/2014)... (PRWEB) September 30, 2014 Brig Hart, ... history, who broke over 500 Diamond-ranked professionals using his ... doing it again. The Life Support System for ... he has been perfecting using his experiences and successes ... month. Using the principles and methodology taught by Brig ...
(Date:9/30/2014)... Farmington, NY (PRWEB) September 30, 2014 Timber ... design/build process for the Olsen family’s reclaimed Douglas fir ... will cover the home’s journey from architectural planning, to the ... Dee Olsen turned to New Energy Works, after following the ... to design and build their dream vacation home on land ...
(Date:9/30/2014)... September 30, 2014 ... , From:        Hope For The ... abarnwell(at)hopeforthewarriors(dot)org , Event:        Got ... , Date:        Thursday, October 2, ... and Navy Club, 901 ...
Breaking Medicine News(10 mins):Health News:New discovery approach accelerates identification of potential cancer treatments 2Health News:Surgeon Creates New Bra for Breast Cancer Patients, Post-Surgery 2Health News:Surgeon Creates New Bra for Breast Cancer Patients, Post-Surgery 3Health News:Brig Hart Announces the First Diamond Elite Representatives using his Life Support System 2Health News:Brig Hart Announces the First Diamond Elite Representatives using his Life Support System 3Health News:Reclaimed Timber Frame Home By New Energy Works Featured in Timber Home Living Magazine 2Health News:Reclaimed Timber Frame Home By New Energy Works Featured in Timber Home Living Magazine 3Health News:Hope For The Warriors' Got Heart, Give Hope Celebration Media Advisory 2
... , , ... US Oncology, Inc . today announced that US Oncology ... Phase III, Multi-center, Open-Label, Randomized Trial of Gemcitabine/Carboplatin (G/C), with or ... HER2-negative metastatic breast cancer. , , ...
... , , , , ... its online boutique, www.chemo-couture.com , featuring inspirational, handcrafted ... and loved ones. , , Inspired ... disease, Jane Bebita and Julie Uhrig joined forces to create an ...
... , , SEOUL, South Korea, July ... 039350) is pleased to announce that its wholly owned subsidiary, ... for the commercial, institutional, and consumer markets, has successfully turned the ... the world) green! Royal Laundry of South San Francisco ...
... , , , ... Resources, one of the world,s leading research and advisory firms focusing ... market in Brazil will grow from $200 million in 2008 to ... the tumor necrosis factor-alpha (TNF-alpha) inhibitors Abbott,s Humira and Schering-Plough,s Remicade ...
... , , BRIDGEWATER, N.J., ... that it is possible to recruit large numbers of women, ... The study, known as GRACE, is the largest study to ... and race differences in response to an HIV-1 therapy -- ...
... , WHITE PLAINS, N.Y. and CAMBRIDGE, Mass., July ... FORMA Therapeutics today announced a partnership to accelerate LLS,s pipeline of ... , The collaboration will begin with a selection of ... to have the most promise of advancing into clinical trials in ...
Cached Medicine News:Health News:US Oncology Research Network Participates in Phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201 2Health News:US Oncology Research Network Participates in Phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201 3Health News:US Oncology Research Network Participates in Phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201 4Health News:HepaHope Korea Subsidiary VASKA Introduces Green Chemicals to U.S. Commercial Laundry Industry 2Health News:Brazil's Rheumatoid Arthritis Drug Market Will Grow $115 Million by 2013 2Health News:New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies 2Health News:New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies 3Health News:New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies 4Health News:New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies 5Health News:New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies 6Health News:New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies 7Health News:New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies 8Health News:The Leukemia & Lymphoma Society and FORMA Therapeutics Enter Collaboration to Bring New Therapies to Patients Faster 2Health News:The Leukemia & Lymphoma Society and FORMA Therapeutics Enter Collaboration to Bring New Therapies to Patients Faster 3
(Date:9/30/2014)... Biomedical Inc. ( www.synapsebiomedical.com ) announced today it ... of its NeuRx DPS® System for ALS patients.  ... enrollment requirement was implanted over a month and ... which is the only medical device approved by ... humanitarian device that obtained approval at the end ...
(Date:9/30/2014)... EXECUTIVE SUMMARY The present report ... - Increasing Demand from Ageing Population to Drive ... past, present and future outlook. The report discusses ... market with outlook to 2017. Statistics include functional ... sub-segments of the industry, ongoing trends and developments, ...
(Date:9/30/2014)... DURHAM, N.C. , Sept. 30, 2014 /PRNewswire/ ... that Viztek LLC (Viztek), a leading provider of ... licensed HeartIT,s zero footprint patent portfolio. The licensed ... to provide access to diagnostic-quality medical images in ... part of the agreement, Viztek and its Subsidiaries ...
Breaking Medicine Technology:Synapse Biomedical Announces the Early Completion of Enrollment in the FDA Post Approval Study for ALS Patients 2Synapse Biomedical Announces the Early Completion of Enrollment in the FDA Post Approval Study for ALS Patients 3North America Nutraceuticals Industry Outlook to 2017- Increasing Demand from Ageing Population to Drive Growth 2North America Nutraceuticals Industry Outlook to 2017- Increasing Demand from Ageing Population to Drive Growth 3
... The AngioJet Xpeedior+120 Rheolytic Thrombectomy catheter is ... performance. Powerful saline jets create a low ... a vacuum effect. Thrombus is drawn into ... the jets, and removed from the body.,AngioJet ...
... combined with a stimulation lead ... Temporary Pacemaker can be used ... pacing is indicated. The device ... as well as diagnostic purposes ...
... a unique left ventricular assist device that helps ... being used in a small group of patients ... of an FDA-approved Feasibility Study. The patient can ... power source for minutes or hours. The Kantrowitz ...
... new Bicycle Ergometer ... braking system which ... reliable service while ... The hyperbolic workload ...
Medicine Products: