Navigation Links
Investigational Oral Multiple Sclerosis Therapy Teriflunomide (Aubagio™(*)) Significantly Reduced Relapse Rate, Disability Progression and Disease Activity
Date:10/5/2011

o research, innovation and the Multiple Sclerosis community, we look forward to providing therapeutic options for patients across the Multiple Sclerosis spectrum."

Teriflunomide has been filed with the FDA in August of 2011 and the EMA filing is expected in the first quarter of 2012.  The results from the TEMSO study are and will be included in each regulatory submission.

TEMSO findings showed that, compared to placebo, teriflunomide once daily:

  • Significantly reduced the risk of annual relapses, the primary endpoint, by 31% (both p<0.001) for 7mg and 14mg doses.

  • Significantly increased the time to first relapse, and allowed significantly more trial participants to remain free of relapses during the two years of the study: 53.7% (7mg, p=0.01 vs. placebo), 56.5% (14mg, p=0.003 vs. placebo) and 45.6% (placebo).

  • The risk of 12-week confirmed disability progression, the key secondary endpoint, was significantly reduced by 30% (p=0.03) for the 14mg dose and numerically reduced by 24% (p=0.08) for the 7mg dose.

  • Improved several standard magnetic resonance imaging (MRI) measures of disease activity as compared to placebo including new or worsening brain lesions with an apparent dose dependent effect in favor of the 14mg dose:
    • Reduced burden of disease (by 39.4% [p=0.03] and 67.4% [p<0.001] for 7mg and 14mg, respectively);
    • Reduced gadolinium-enhancing T1 lesions (relative risk reduction of 57% and 80%, p<0.001 for both doses);
    • Reduced unique active lesions per scan (relative risk reduction of 48% and 69%, p<0.001 for both doses).

Similar adverse events, serious adverse events, and adverse events leading to treatment discontinuation were observed with teriflu
'/>"/>

SOURCE Sanofi; Genzyme
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Puma Biotechnology Announces Licensing Agreement with Pfizer for the Development and Commercialization of Neratinib, an Investigational Pan-HER Inhibitor; Closes $55 Million Private Placement and Completes Merger
2. Positive Phase III Data on Bayers Investigational Drug Radium-223 Chloride Show Significant Increase in Overall Survival
3. New Study Published in New England Journal of Medicine Shows Investigational BIBF 1120 Demonstrated Positive Trend in Reducing Lung Function Loss in Idiopathic Pulmonary Fibrosis
4. Bayer to Present New Data Evaluating Investigational Oncology Compounds at 2011 ECCO-ESMO Congress
5. Boehringer Ingelheim Broadens Its Breast Cancer Clinical Trial Program for the Investigational Compound Afatinib
6. FDA Grants Fast Track Designation to Bayers Investigational Compound Radium-223 Chloride for the Treatment of Castration-Resistant Prostate Cancer That Has Spread to the Bone
7. CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine
8. Marshall Edwards Announces FDA Approval of Investigational New Drug Application for Lead Candidate ME-143
9. Takeda Resubmits New Drug Applications in the U.S. for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone
10. Positive Results for Investigational Compound Lyxumia® (Lixisenatide) Presented at American Diabetes Associations 71st Annual Scientific Sessions
11. Morphotek, Inc. Announces That Two Investigational Drugs Have Received Orphan Drug Designations
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/1/2015)... 2015  Legendary actor and director Danny Glover ... campaign designed to educate and encourage patients with neurologic ... Affect (PBA) and to speak with their physician. The ... the ability to cry and laugh on cue and ... by people living with PBA episodes. While ...
(Date:5/1/2015)... 2015  Misonix, Inc. (NASDAQ: MSON ), ... and markets innovative therapeutic ultrasonic products for spine ... laparoscopic surgery and other surgical applications, announced today ... third quarter fiscal year 2015 on Thursday, May ... call that same day, Thursday, May 7, 2015, ...
(Date:4/30/2015)... April 30, 2015 /PRNewswire/ - Pivotal Therapeutics Inc. ... with a focus on Omega-3 therapies for cardiovascular ... highlights and financial results for the fiscal year ... herein are in Canadian dollars unless otherwise stated. ... significant, with the right strategic partners and additional ...
Breaking Medicine Technology:Danny Glover Joins PBA Facts Campaign, to Educate and Build Awareness of Pseudobulbar Affect (PBA), a Little Known but Widespread Neurologic Condition 2Danny Glover Joins PBA Facts Campaign, to Educate and Build Awareness of Pseudobulbar Affect (PBA), a Little Known but Widespread Neurologic Condition 3Misonix, Inc. To Report Third Quarter Fiscal Year 2015 Financial Results On Thursday, May 7, 2015 2Pivotal Therapeutics Announces 2014 Financial Results 2Pivotal Therapeutics Announces 2014 Financial Results 3Pivotal Therapeutics Announces 2014 Financial Results 4Pivotal Therapeutics Announces 2014 Financial Results 5Pivotal Therapeutics Announces 2014 Financial Results 6
... HealthWarehouse.com, Inc. (OTC Bulletin Board: HEWA), a ... consummated two separate transactions to acquire all the online ... medications, diabetics supplies, and medical equipment, and merge with ... "The combination will bring together two companies committed ...
... and INGELHEIM, Germany, Feb. 15, 2011 Pfenex ... the Pfenex Expression Technology™ platform and Boehringer Ingelheim ... leader in biopharmaceutical contract development and manufacture, announced ... agreement. It provides Boehringer Ingelheim with non-exclusive access ...
Cached Medicine Technology:HealthWarehouse.com Acquires Online Division of Hocks Pharmacy 2Pfenex Inc. and Boehringer Ingelheim Announce Non-Exclusive Strategic Agreement for the Use of Pfenex Expression Technology™ 2Pfenex Inc. and Boehringer Ingelheim Announce Non-Exclusive Strategic Agreement for the Use of Pfenex Expression Technology™ 3
(Date:5/4/2015)... Today, Cireson reveals the following key announcements:, ... to strengthen core service & asset management solutions , ... Microsoft System Center and Cireson via Microsoft Azure in ... Company transitioning from a direct sales presence to 100% ... expanding new solutions for password reset management, gamification, self-service ...
(Date:5/3/2015)... Michigan (PRWEB) May 03, 2015 Barbara Crone has ... to enhance the well being of the men, women and families ... hospital, followed by providing care for families in the home. ... Adult Nurse Practitioner began wondering if I could complete their care ... my own children with my mentor Nurse Midwife, I knew it ...
(Date:5/3/2015)... San Francisco, CA (PRWEB) May 03, 2015 ... International (CFHI), announced it will be awarding the ... Scholars, Jennifer Knight and Selemawit Ghebrendrias, are the deserving ... and champion for global service, Harris Llewellyn Wofford. The ... global service and passion for global health. , ...
(Date:5/3/2015)... BolehVPN ” was featured on NewsWatch as part of its ... products available to consumers. Scott Steinberg, a technology expert and ... viewers how to protect their private information. , A lot ... even more so online. It helps everyone stay connected with ... In terms of work, the internet makes things more efficient. ...
(Date:5/3/2015)... 03, 2015 SpineFrontier, a Less Exposure ... FDA to produce and market their new sacroiliac joint ... used in outpatient settings and is compatible with both ... approach has been extensively researched and refined by SpineFrontier, ... use this approach in conjunction with a sacroiliac joint ...
Breaking Medicine News(10 mins):Health News:Cireson Unveils New Microsoft Cloud & System Center Strategy 2Health News:Cireson Unveils New Microsoft Cloud & System Center Strategy 3Health News:Cireson Unveils New Microsoft Cloud & System Center Strategy 4Health News:Women's Excellence In Midwifery Welcomes Barbara Crone 2Health News:SF-based Global Health Non-Profit Awards Harris Wofford Global Service Fellowship 2Health News:SF-based Global Health Non-Profit Awards Harris Wofford Global Service Fellowship 3Health News:A Method to Keep Private Information Secure was Featured on NewsWatch Television 2
... LITTLE FALLS, N.J., Aug. 3 CANTEL MEDICAL CORP. ... has continued the expansion of its water purification and filtration segment ... LLC. G.E.M. designs, builds, installs and services high quality water ... business had pre-acquisition revenues of approximately $3.5 million. This cash ...
... the risk of trouble, expert says, , MONDAY, Aug. 3 ... physical education programs to battle the childhood obesity epidemic, the ... dramatically, Ohio State University researchers report. , In fact, ... to physical education (PE) increased 150 percent -- from 24,000 ...
... BERKELEY HEIGHTS, N.J., Aug. 3 Authentidate ... worldwide provider of secure Health Information Exchange and ... of America, Inc., a leading provider of home ... South Carolina, will implement Authentidate,s Inscrybe(TM) Healthcare web-based ...
... , Expert recommends parents and schools ... ANN ARBOR, Mich., Aug. 3 As a bright, young ... had everything going for her. , , But when ... on hand, Laura landed on her head fracturing her neck and damaging ...
... , ARDEE, Ireland, Aug. 3 Warner Chilcott Limited ... two Paragraph IV Certification Notices from Lupin Ltd. ("Lupin"). The ... Abbreviated New Drug Applications (ANDAs) by Lupin for generic versions of ... , , LOESTRIN 24 FE, which was launched ...
... , , LEAGUE CITY, Texas, Aug. ... been dedicated to the insurance needs of seniors, with an unyielding ... Agent. This has never been more evident than in the introduction ... 2009. , , With the advent of the ...
Cached Medicine News:Health News:Cantel Medical's Mar Cor Purification Subsidiary Acquires G.E.M. Water Systems ... Establishing a Nationwide Reach in Water Treatment 2Health News:Cantel Medical's Mar Cor Purification Subsidiary Acquires G.E.M. Water Systems ... Establishing a Nationwide Reach in Water Treatment 3Health News:Gym Class Injuries Up 150 Percent 2Health News:Gym Class Injuries Up 150 Percent 3Health News:Medical Services of America Selects Authentidate's Inscrybe Healthcare to Standardize Healthcare Order Process Management 2Health News:Medical Services of America Selects Authentidate's Inscrybe Healthcare to Standardize Healthcare Order Process Management 3Health News:Medical Services of America Selects Authentidate's Inscrybe Healthcare to Standardize Healthcare Order Process Management 4Health News:Cheerleading is Leading Cause of Catastrophic Injury in Young Women 2Health News:Cheerleading is Leading Cause of Catastrophic Injury in Young Women 3Health News:Warner Chilcott Announces Receipt of Paragraph IV Certification Notices 2Health News:Warner Chilcott Announces Receipt of Paragraph IV Certification Notices 3Health News:SLAICO Takes the Medicare Supplement Application Online - Eliminating All Paperwork Offline. 2