Biogen Idec (BIIB) Reports Publication of Significant Results from Phase 3 DEFINE and CONFIRM
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Biogen Idec (Nasdaq: BIIB) announced that detailed results from its two pivotal clinical trials evaluating oral BG-12 (dimethyl fumarate) for the treatment of multiple sclerosis (MS) were published in the Sept. 20, 2012 issue of The New England Journal of Medicine (NEJM).
Data from the Phase 3 DEFINE and CONFIRM studies show that dimethyl fumarate (240 mg), administered twice daily (BID) or three times daily (TID), demonstrated significant and clinically meaningful reductions in MS relapses and brain lesions in patients with relapsing-remitting multiple sclerosis (RRMS) compared to placebo, as well as showed benefit in slowing the progression of the disease. Dimethyl fumarate is currently under review by regulatory authorities in the United States, European Union, Australia, Canada and Switzerland.
“The publication of both dimethyl fumarate pivotal studies in NEJM is another achievement for this important investigational therapy,” said Katherine Dawson, M.D., senior medical director, Biogen Idec Neurology Research and Development and Biogen Idec lead author on both dimethyl fumarate manuscripts in NEJM. “The data from its clinical development program consistently indicate that dimethyl fumarate may provide tangible benefits and address existing treatment needs of people living with MS. We are working closely with regulatory authorities across the globe with the aim of making the review of dimethyl fumarate as quick as possible.”
Together, the DEFINE and CONFIRM manuscripts in NEJM summarize the positive Phase 3 clinical data set for dimethyl fumarate, which formed the foundation for its regulatory filings around the world.
DEFINE was a two-year global study that evaluated dimethyl fumarate (240 mg, BID or TID) compared to placebo in people with RRMS. Results showed that both dimethyl fumarate BID and TID met the study’s primary endpoint by significantly reducing the proportion of patients who relapsed by 49 percent and 50 percent (p<0.0001 for both; reported in NEJM as <0.001 due to journal requirement that p-values smaller than 0.001 be reported as p<0.001), respectively, at two years compared to placebo. Both dosing regimens also met all secondary endpoints in the study.
“Because MS is a chronic disease, we look for treatment options that not only control relapses but also slow patients’ disease progression for as long as possible,” said Ralf Gold, Ph.D., professor/chair of the Department of Neurology at St. Josef-Hospital/Ruhr-University in Bochum, Germany, and lead author on the DEFINE manuscript in NEJM. “In DEFINE, dimethyl fumarate demonstrated efficacy, as well as positive safety and tolerability profiles, which is a very attractive combination for an MS treatment.”
Like DEFINE, CONFIRM was a two-year global clinical trial that investigated dimethyl fumarate (240 mg, BID or TID) versus placebo in people with RRMS. The study also included an active reference comparator of glatiramer acetate (GA; 20 mg subcutaneous daily injection) versus placebo. Results showed that both dimethyl fumarate BID and TID met the study’s primary endpoint by significantly reducing annualized relapse rate (ARR) by 44 percent and 51 percent (p<0.0001 for both; reported in NEJM as p<0.001 due to journal requirement that p-values smaller than 0.001 be reported as p<0.001), respectively, versus placebo at two years. In addition, both dosing regimens of dimethyl fumarate met all secondary relapse and magnetic resonance imaging (MRI) endpoints in the study. While not statistically significant, dimethyl fumarate showed a clinically meaningful reduction in 12-week confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS).
The GA data versus placebo in CONFIRM were generally consistent with its product labeling.
Data from the Phase 3 DEFINE and CONFIRM studies show that dimethyl fumarate (240 mg), administered twice daily (BID) or three times daily (TID), demonstrated significant and clinically meaningful reductions in MS relapses and brain lesions in patients with relapsing-remitting multiple sclerosis (RRMS) compared to placebo, as well as showed benefit in slowing the progression of the disease. Dimethyl fumarate is currently under review by regulatory authorities in the United States, European Union, Australia, Canada and Switzerland.
“The publication of both dimethyl fumarate pivotal studies in NEJM is another achievement for this important investigational therapy,” said Katherine Dawson, M.D., senior medical director, Biogen Idec Neurology Research and Development and Biogen Idec lead author on both dimethyl fumarate manuscripts in NEJM. “The data from its clinical development program consistently indicate that dimethyl fumarate may provide tangible benefits and address existing treatment needs of people living with MS. We are working closely with regulatory authorities across the globe with the aim of making the review of dimethyl fumarate as quick as possible.”
Together, the DEFINE and CONFIRM manuscripts in NEJM summarize the positive Phase 3 clinical data set for dimethyl fumarate, which formed the foundation for its regulatory filings around the world.
DEFINE was a two-year global study that evaluated dimethyl fumarate (240 mg, BID or TID) compared to placebo in people with RRMS. Results showed that both dimethyl fumarate BID and TID met the study’s primary endpoint by significantly reducing the proportion of patients who relapsed by 49 percent and 50 percent (p<0.0001 for both; reported in NEJM as <0.001 due to journal requirement that p-values smaller than 0.001 be reported as p<0.001), respectively, at two years compared to placebo. Both dosing regimens also met all secondary endpoints in the study.
“Because MS is a chronic disease, we look for treatment options that not only control relapses but also slow patients’ disease progression for as long as possible,” said Ralf Gold, Ph.D., professor/chair of the Department of Neurology at St. Josef-Hospital/Ruhr-University in Bochum, Germany, and lead author on the DEFINE manuscript in NEJM. “In DEFINE, dimethyl fumarate demonstrated efficacy, as well as positive safety and tolerability profiles, which is a very attractive combination for an MS treatment.”
Like DEFINE, CONFIRM was a two-year global clinical trial that investigated dimethyl fumarate (240 mg, BID or TID) versus placebo in people with RRMS. The study also included an active reference comparator of glatiramer acetate (GA; 20 mg subcutaneous daily injection) versus placebo. Results showed that both dimethyl fumarate BID and TID met the study’s primary endpoint by significantly reducing annualized relapse rate (ARR) by 44 percent and 51 percent (p<0.0001 for both; reported in NEJM as p<0.001 due to journal requirement that p-values smaller than 0.001 be reported as p<0.001), respectively, versus placebo at two years. In addition, both dosing regimens of dimethyl fumarate met all secondary relapse and magnetic resonance imaging (MRI) endpoints in the study. While not statistically significant, dimethyl fumarate showed a clinically meaningful reduction in 12-week confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS).
The GA data versus placebo in CONFIRM were generally consistent with its product labeling.
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