Navigation Links
Biogen-Idec's BG-12 Shines At the Top of the Charts in the Treatment of Relapsing-Remitting Multiple Sclerosis

NEW YORK, Nov. 4, 2011 /PRNewswire/ -- Citeline, an Informa business unit, and the world's leading research authority on pharmaceutical clinical trials recently reviewed results presented at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS), a major multiple sclerosis conference which was held October 19-22, 2011 in Amsterdam.  

Phase III study of oral BG-12 in relapsing-remitting multiple sclerosis sparked excitement as the details of the Determination of the Efficacy and safety of oral Fumarate IN rElapsing-remitting MS (DEFINE) trial were presented at the meeting, quickly boosting BG-12 to stardom status.

The DEFINE study, supported by Biogen-Idec, showed that 240 mg of BG-12, administered either twice (BID) or three times a day (TID), significantly reduced the proportion of patients who relapsed by 49 percent and 50 percent, respectively, at two years compared with placebo.  It is believed that BG-12 has dual anti-inflammatory and neuroprotective effects via the Nrf2 pathway.  Citeline's analyst Dr. Heidi Chen shared the latest buzz about BG-12 as a promising therapeutic for relapsing-remitting multiple sclerosis patients, "BG-12 offers an attractive package with its distinct and novel mechanism of action, which really adds a sweet edge to the competition."  

BG-12 received Fast Track designation from the U.S. Food and Drug Administration (FDA) in 2008.  Since the initial results of the DEFINE study were announced in April 2011, BG-12 continues to be a strong contender with its encouraging safety profile.  Dr. Heidi Chen from Citeline noted, "The combined portfolio of efficacy and a robust safety data, BG-12 could become a first line of defense in the treatment of RRMS."  The top-line results of DEFINE trial were replicated in the second pivotal Phase III trial CONFIRM, which significantly reduced annualized relapse rate (ARR) by 44 percent for BID (p< 0.0001) and by 51 percent for TID (p< 0.0001) versus placebo at two years.  Biogen-Idec announced the results of the CONFIRM trial only days after it presented detailed data of the DEFINE study at the 5th Joint Triennial Congress of the European and Americas Committees on Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in October 2011.   In fact, results from the CONFIRM study showed that BG-12 beats Teva's Copaxone, which reduced the ARR by only 29 percent (p< 0.02) compared with placebo at two years.

With two robust and positive pivotal clinical trials that exposed BG-12 to over 2,600 patients, the drug is well positioned as a top MS therapy of choice and a formidable competitor to Gilenya from Novartis, which gained FDA approval in September 2010.  

About Citeline

Citeline ( provides the world's most comprehensive real-time R&D intelligence to the pharmaceutical industry, covering global clinical trial, investigator and drug intelligence. Our data is drawn from over 18,000 unique sources and analyzed by the industry's largest team – over 250 full-time expert analysts and editors.

All company, brand or product names contained in this document may be trademarks or registered trademarks of their respective holders.

SOURCE Citeline
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Former Miss USA Shawnae Jebbia Shines with Siemens Pure
2. Muenster Memorial Hospital Selects ChartSmart emr®
3. Sharkey Issaquena Community Hospital Implements ChartSmart emr®
4. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
5. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
6. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
7. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
8. Sixty-One Percent of Newly Diagnosed Parkinsons Disease Patients Do Not Receive Any Drug Treatment in the First Year of Diagnosis
9. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
10. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
11. Wyeths Torisel and Roche/Genentechs Avastin Will Challenge Pfizers Sutent to Become the Clinical Gold Standard for Treatment of Metastatic Renal Cell Carcinoma
Post Your Comments:
(Date:6/24/2016)... June 24, 2016 The Academy of Managed ... recommendations that would allow biopharmaceutical companies to more ... that make formulary and coverage decisions, a move that ... new medicines. The recommendations address restrictions in ... on the drug label, a prohibition that hinders decision ...
(Date:6/24/2016)... , June 24, 2016 ... Market by Type (Standard Pen Needles, Safety Pen Needles), ... (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) ... MarketsandMarkets, This report studies the market for the forecast ... to reach USD 2.81 Billion by 2021 from USD ...
(Date:6/23/2016)... June 23, 2016  MedSource announced today that ... e-clinical software solution of choice.  This latest decision ... value to their clients by offering a state-of-the-art ... relationship establishes nowEDC as the EDC platform of ... full-service clients.  "nowEDC has long been a preferred ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now ... of Final Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. ... Final Cut Pro X users can now reveal the media of their split ...
(Date:6/27/2016)... ... 27, 2016 , ... A revolution is underway. Brooklyn-based ... experience for the millions of people who require these medical transport services annually. ... through the use of technology. Now, SmartEMS has put forth an industry-changing app ...
(Date:6/26/2016)... , ... June 26, 2016 , ... On June 10-11, ... of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, ... the city’s history as home to some of the world’s leading providers of cereal ...
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer ... through a fitness app. The fitness app plans to fix the two major problems leading ... a one size fits all type program , They don’t eliminate all the ...
(Date:6/25/2016)... ... , ... Austin residents seeking Mohs surgery services, can now turn to Dr. ... Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to include ... in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn ...
Breaking Medicine News(10 mins):