VUMERITY Offers the Efficacy Demonstrated by dimethyl fumarate Across 2 Pivotal Trials1

The efficacy of VUMERITY is based upon bioavailability studies in patients with relapsing forms of multiple sclerosis and healthy subjects comparing oral dimethyl fumarate delayed-release capsules to VUMERITY delayed-release capsules. The clinical studies described below were conducted using dimethyl fumarate.

Study 1

A 2-year, randomized, double-blind, placebo-controlled study of 1234 patients with relapsing-remitting multiple sclerosis (RRMS)1

*The only approved and recommended dose for dimethyl fumarate is 240 mg BID.4

Key inclusion criteria1

Experienced at least 1 relapse over the year preceding the trial

OR

Had a brain magnetic resonance imaging (MRI) scan demonstrating at least 1 gadolinium-enhancing (Gd+) lesion within 6 weeks of randomization

AND

An Expanded Disability Status Scale (EDSS) score ranging from 0 to 5

Key exclusion criteria2
  • Interferon-beta or glatiramer acetate within 3 months of randomization
  • An infusion disease-modifying therapy (DMT) or other select therapies* within 6 months of randomization
  • Primary progressive multiple sclerosis, secondary progressive multiple sclerosis, or progressive relapsing multiple sclerosis
  • Any major disease that would preclude participation in a clinical trial

*Please see full Prescribing Information for additional information.

Evaluations1

Neurological evaluations

Performed at baseline, every 3 months, and at time of suspected relapse

MRI evaluations

Performed in 44% of patients at baseline, month 6, and years 1 and 2

69% of patients treated with dimethyl fumarate BID completed 96 weeks of treatment compared to 65% of patients taking placebo1

Study 2

A 2-year, multicenter, randomized, double-blind, placebo-controlled study that also included an open-label comparator arm in patients with RRMS1

*The only approved and recommended dose for dimethyl fumarate is 240 mg BID.4

Key inclusion criteria1

Experienced at least 1 relapse over the year preceding the trial

OR

Had a brain magnetic resonance imaging (MRI) scan demonstrating at least 1 gadolinium-enhancing (Gd+) lesion within 6 weeks of randomization

AND

An Expanded Disability Status Scale (EDSS) score ranging from 0 to 5

Key exclusion criteria3
  • Interferon-beta or glatiramer acetate within 3 months of randomization
  • An infusion disease-modifying therapy (DMT) or other select therapies* within 6 months of randomization
  • Progressive forms of multiple sclerosis
  • Any major disease that would preclude participation in a clinical trial

*Please see full Prescribing Information for additional information.

Evaluations1

Neurological evaluations

Performed at baseline, every 3 months, and at time of suspected relapse

MRI evaluations

Performed in 48% of patients at baseline, month 6, and years 1 and 2

70% of patients treated with dimethyl fumarate BID completed 96 weeks of treatment compared to 64% of patients taking placebo1