Biogen Idec has announced that the FDA ( Food and Drug Administration ) has approved Tecfidera ( Dimethylfumarate ), a new first-line oral treatment for people with relapsing forms of multiple sclerosis.

Tecfidera has been clinically proven to significantly reduce important measures of disease activity, including relapses and development of brain lesions, as well as to slow disability progression over time, while demonstrating a favorable safety and tolerability profile.

The FDA approval of Tecfidera is based on data from a robust clinical development program that included DEFINE and CONFIRM, two global phase 3 studies that enrolled more than 2,600 patients. In the ongoing extension study, ENDORSE, some patients receiving Tecfidera have been followed for more than four years.

In DEFINE, Tecfidera, administered twice daily, significantly reduced the proportion of patients who relapsed by 49% ( p less than 0.0001 ), the annualized relapse rate ( ARR ) by 53% ( p less than 0.0001 ), and 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale ( EDSS ), by 38% ( p=0.0050 ) compared to placebo at two years.
In CONFIRM, twice-daily Tecfidera significantly reduced ARR by 44% ( p less than 0.0001 ) and the proportion of patients who relapsed by 34% ( p=0.0020 ) compared to placebo at two years. While not statistically significant, Tecfidera has showed a 21% reduction in 12-week confirmed disability progression in CONFIRM.
Both studies also showed that Tecfidera significantly reduced lesions in the brain compared to placebo, as measured by magnetic resonance imaging ( MRI ).

The most common side effects associated with Tecfidera are flushing and gastrointestinal ( GI ) events ( i.e., diarrhea, nausea and abdominal pain ). In clinical studies, flushing symptoms usually began soon after initiating treatment, were mostly mild to moderate, and usually improved or resolved over time. The incidence of GI events was higher early in the course of treatment ( primarily in the first month ) and decreased over time. Overall, clinical trial discontinuations due to flushing and GI events were low.

Tecfidera may decrease lymphocyte counts in some patients. In clinical studies, mean lymphocyte counts decreased during the first year of treatment and then remained stable. The incidence of infections and serious infections was similar in Dimethylfumarate-treated patients and those on placebo. There were no opportunistic infections in Dimethylfumarate-treated patients. In patients with low lymphocyte counts, there was no increased incidence in serious infections. Patients taking Tecfidera should have a complete blood count ( CBC ) before starting treatment to measure lymphocyte counts. A follow up CBC is recommended annually and at the discretion of the treating physician.

It is believed that Tecfidera provides a new approach to treating relapsing forms of multiple sclerosis by activating the Nrf2 pathway, although its exact mechanism of action is unknown. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like multiple sclerosis.

The starting dose for Tecfidera is 120 mg twice a day orally. After seven days, the recommended dose increases to 240 mg twice a day orally.

Tecfidera has a Pregnancy Category C. Before starting treatment with Tecfidera, women should talk to their doctor if they are pregnant or planning to become pregnant.
Source: Biogen Idec, 2013

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