GEN Exclusives

More »

GEN News Highlights

More »
Oct 21, 2011

Positive Results Reported for Biogen Idec’s Oral MS Drug in First Phase III Study

  • Biogen Idec reported positive data from a Phase III study evaluating oral BG-12 (dimethyl fumarate) therapy in patients with relapsing-remitting multiple sclerosis (RRMS). Two-year data from the Define study showed that compared with placebo therapy, treatment using oral BG-12 either twice a day (BID) or three times a day (TID) significantly reduced the proportion of patients who relapsed by 49% and 50%, respectively.

    The 1,237-patient study in addition showed that BG-12 BID and TID reduced the annualized relapse rate (ARR) by 53% and 48%, respectively, and the risk of disability progression by 38% and 34%, respectively. MRI evaluation showed that at two years, treatment with BG-12 BID and TID had, respectively, reduced the mean number of new or newly enlarging T2 hyperintense lesions by 85% and 74%, reduced the mean number of Gd+ lesions by 90% and 73%, and led to 72% and 63% lower numbers of new T1 hypointense lesions.   

    Topline data from a second Phase III study, Confirm, are expected by the end of 2011. “Results from our second Phase III trial, Confirm, will provide additional insight into BG-12’s profile, as well as a comprehensive dataset to further discussions with regulatory authorities,” comments Doug Williams, Ph.D., Biogen Idec executive vp for R&D. “The significant clinical and radiological responses in Define are further evidence that BG-12 may become an oral therapy of choice for MS patients.”

     


Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Block That Microbiome Metaphor!

Which way of thinking about the microbiome would best integrate the virome’s contributions?