April 26, 2012 (New Orleans, Louisiana) — Full results of
a second phase 3 trial of oral BG-12 (dimethyl fumarate, Biogen Idec) in
relapsing-remitting multiple sclerosis (MS) show that the drug significantly
reduced annualized relapse rates vs placebo and compared favorably to
glatiramer acetate (Copaxone, Teva Pharmaceuticals) in a reference group.
a second phase 3 trial of oral BG-12 (dimethyl fumarate, Biogen Idec) in
relapsing-remitting multiple sclerosis (MS) show that the drug significantly
reduced annualized relapse rates vs placebo and compared favorably to
glatiramer acetate (Copaxone, Teva Pharmaceuticals) in a reference group.
Results of the Comparator and an Oral Fumarate in RRMS
(CONFIRM) trial showed that the still-investigational oral drug met the study’s
primary endpoint, significantly reducing the annualized relapse rate by 44% for
the twice-daily (BID) dose and by 51% for the thrice-daily (TID) dose vs
placebo at 2 years. Treatment also reduced T1 lesions, T2 lesions, and the risk
for relapse, as well as the 12-week confirmed disability progression, although
this latter finding was not statistically significant.
(CONFIRM) trial showed that the still-investigational oral drug met the study’s
primary endpoint, significantly reducing the annualized relapse rate by 44% for
the twice-daily (BID) dose and by 51% for the thrice-daily (TID) dose vs
placebo at 2 years. Treatment also reduced T1 lesions, T2 lesions, and the risk
for relapse, as well as the 12-week confirmed disability progression, although
this latter finding was not statistically significant.
Principal investigator of the CONFIRM trial, Robert J.
Fox, MD, neurologist and medical director of the Mellen Center for MS at the
Cleveland Clinic, Ohio, presented full results here at the American Academy of
Neurology 64th Annual Meeting. Topline results were released October 26, 2011,
and reported by Medscape Medical News at that time.
Fox, MD, neurologist and medical director of the Mellen Center for MS at the
Cleveland Clinic, Ohio, presented full results here at the American Academy of
Neurology 64th Annual Meeting. Topline results were released October 26, 2011,
and reported by Medscape Medical News at that time.
CONFIRM is the second of 2 phase 3 trials of BG-12, both
funded by Biogen Idec. The other, called the Determination of the Efficacy and
Safety of Oral Fumarate in Relapsing-Remitting MS (DEFINE) trial, was presented
last fall at the 5th Joint Triennial Congress of the European and Americas
Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS).
funded by Biogen Idec. The other, called the Determination of the Efficacy and
Safety of Oral Fumarate in Relapsing-Remitting MS (DEFINE) trial, was presented
last fall at the 5th Joint Triennial Congress of the European and Americas
Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS).
“The results are quite consistent with what was seen
in the previous phase 3 trial, the DEFINE trial, and suggest that this drug has
quite robust efficacy, and an acceptable safety and tolerability profile,”
Dr. Fox concluded.
in the previous phase 3 trial, the DEFINE trial, and suggest that this drug has
quite robust efficacy, and an acceptable safety and tolerability profile,”
Dr. Fox concluded.
In a statement, the company confirmed that data from
CONFIRM and DEFINE were included in regulatory applications that were submitted
as part of a New Drug Application (NDA) to the Food and Drug Administration
(FDA) in the United States and a Marketing Authorization Application (MAA) to
the European Medicines Agency (EMA) earlier this year.
CONFIRM and DEFINE were included in regulatory applications that were submitted
as part of a New Drug Application (NDA) to the Food and Drug Administration
(FDA) in the United States and a Marketing Authorization Application (MAA) to
the European Medicines Agency (EMA) earlier this year.
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