Tecfidera (dimethyl fumarate) capsules, also known as BG-12, approved by FDA

Biogen Idec received approval today from the FDA for Tecfidera (dimethyl fumarate). Tecfidera is the branded name for the oral capsule previously known as BG-12 by many in the multiple sclerosis community.

Biogen Idec, the product’s manufacturer, states, “In DEFINE, TECFIDERA, administered twice daily, significantly reduced the proportion of patients who relapsed by 49 percent (p<0.0001), the annualized relapse rate (ARR) by 53 percent (p<0.0001), and 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent (p=0.0050) compared to placebo at two years. In CONFIRM, twice-daily TECFIDERA significantly reduced ARR by 44 percent (p<0.0001) and the proportion of patients who relapsed by 34 percent (p=0.0020) compared to placebo at two years. While not statistically significant, TECFIDERA showed a 21 percent 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).”

In its press release Biogen Idec states that Tecfidera will offer patients with relapsing forms of MS a new, effective and convenient treatment option, that has been proven to reduce relapses and disability progression in clinical trials.

The FDA has reviewed the large amount of data on the drug stating, “Results from two clinical trials showed that those taking Tecfidera had fewer MS relapses compared to people taking an inactive pill (placebo). One of the trials showed that those taking Tecfidera experienced a worsening of disability less often than patients taking a placebo.”

Tecfidera may decrease a person’s white blood cell count (lymphocytes). Lymphocytes help protect the body from infection and low counts can raise the risk of infection, although no significant increase in infections was seen in patients taking Tecfidera in clinical trials. Before starting treatment, and annually thereafter, the FDA recommends that the patient’s white blood cell count be assessed by their health care provider.”

The FDA also commented on the side effect profile of Tecfidera, noting that “flushing (warmth and redness) and stomach problems (nausea, vomiting, and diarrhea) were the most common adverse reactions reported by patients receiving Tecfidera in clinical trials, especially at the start of therapy. These side effects may decrease over time.”

Additionally a recent complete blood cell count (CBC) (i.e., within 6 months) is recommended before initiation of therapy to identify patients with pre-existing low lymphocyte counts.

If you wish to view the full prescribing information you can visit Tecfidera.com. Tecfidera is available as hard gelatin delayed-release capsules containing 120 mg or 240 mg of dimethyl fumarate.

As a reminder, never start, stop or change any medication without consulting with your healthcare professional.

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