The U.S. Food and Drug Administration (FDA) has announced its approval of Tecfidera™ (dimethyl fumarate), a new first-line oral treatment for people with relapsing forms of multiple sclerosis. Biogen Idec has stated it will make this oral capsule available to people living with MS in the United States in the coming days.
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.
The FDA approval of Tecfidera is based on data from a clinical development program that included DEFINE and CONFIRM, two global Phase III studies that enrolled more than 2,600 people. In the ongoing extension study, ENDORSE, some participants receiving Tecfidera have been followed for more than four years.
In DEFINE, Tecfidera administered twice daily significantly reduced the proportion of people who relapsed by 49 percent, the annualized relapse rate (ARR) by 53 percent, and 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent compared to placebo at two years.
In CONFIRM, twice-daily Tecfidera reduced ARR by 44 percent and the proportion of people who relapsed by 34 percent 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 clinical trials, patients treated with dimethyl fumarate had less disease activity when compared to patients on placebo – whether they were in the early stages of MS or had more established disease,” said Robert Fox, M.D., medical director of the Mellen Center for Multiple Sclerosis at Cleveland Clinic, lead investigator of the CONFIRM study, and a paid advisor for Biogen Idec for projects not related to Tecfidera clinical development.
The most common side effects associated with Tecfidera are flushing and gastrointestinal (GI) events (such as 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 people. 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 Tecfidera-treated individuals and those on placebo. There were no opportunistic infections in Tecfidera-treated individuals. In those with low lymphocyte counts, there was no increased incidence in serious infections.
People 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.
Tecfidera has not been studied in people with pre-existing low lymphocyte counts and caution should be exercised when treating these individuals. 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.
For complete Tecfidera prescribing information, please visit Tecfidera.com.