Navigation Links
Biogen-Idec's BG-12 Shines At the Top of the Charts in the Treatment of Relapsing-Remitting Multiple Sclerosis
Date:11/4/2011

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 (www.citeline.com) 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:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... , Feb. 8, 2016  Echo Therapeutics, ... device company focused on non-invasive continuous glucose ... today announced that it will host a ... 17, 2015 at 9:00 a.m. Eastern Time ... its corporate strategy, advancements in its CGM ...
(Date:2/8/2016)... , Feb. 8, 2016 ... the "Global Skin Protective Equipment Market 2016-2020" ... --> http://www.researchandmarkets.com/research/fqx6nz/global_skin ) has announced the addition ... 2016-2020" report to their offering. ... ) has announced the addition of the ...
(Date:2/8/2016)... , Feb. 8, 2016   HighPoint ... November Research Group (NRG),s pharmacovigilance technology services division.  ... consulting services and an Oracle Argus Specialized partner, ... to Life Sciences companies. --> ... expands HighPoint,s life sciences capabilities and provides a ...
Breaking Medicine Technology:
(Date:2/8/2016)... (PRWEB) , ... February 08, 2016 , ... ... offices in Houma, LA, celebrates the beginning of a new charity campaign. As ... assist Court Appointed Special Advocates (CASA). In the belief that children deserve a ...
(Date:2/8/2016)... ... February 08, 2016 , ... If you are feeling that your clothes are ... alone. According to the Center for Disease Control and Prevention (CDC), 34.9% of U.S. ... certain types of cancer, some of the leading causes of preventable death. February ...
(Date:2/8/2016)... ... February 08, 2016 , ... Local insurance agency ... Venice, FL area, has initiated a fundraiser for a two year old little ... days after Christmas. To support this beautiful child who is facing life’s journey ...
(Date:2/8/2016)... ... February 08, 2016 , ... Eating disorders and post-traumatic ... of women and men with eating disorders report a history of trauma, research ... development of an eating disorder. , At the 2016 iaedp Symposium, the ...
(Date:2/8/2016)... ... February 08, 2016 , ... The Association of ... AHCC and the Home Health and Hospice ICD-10 Transition Workgroup are working closely ... coding guidance and clarifications, to address concerns over the use of 'A' as ...
Breaking Medicine News(10 mins):