The US Food and Drug Administration (FDA) has approved Biogen Idec's Tecfidera (dimethyl fumarate), a new first-line oral capsule for people suffering from relapsing forms of multiple sclerosis (MS).
Tecfidera reduces relapses and development of brain lesions, to slow disability progression over time.
The FDA approval of Tecfidera was based on two global phase 3 studies, DEFINE and CONFIRM, where in the drug was individually administered twice daily.
In DEFINE, Tecfidera reduced the proportion of patients who relapsed by 49% (p<0.0001), the annualized relapse rate (ARR) by 53% (p<0.0001), and 12-week confirmed disability progression by 38% (p=0.0050) compared to placebo within two years.
In CONFIRM, Tecfidera reduced the proportion of patients who relapsed by 34% (p=0.0020), ARR by 44% (p<0.0001), and 12-week confirmed disability progression by 21% compared to placebo within two years.
Biogen Idec CEO George Scangos said, "With the FDA approval of Tecfidera, we will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill - a combination we believe will have a significant positive impact on the way people live with this chronic disease."
In addition, both the studies demonstrated that Tecfidera significantly reduced lesions in the brain compared to placebo, as per magnetic resonance imaging.
Cleveland Clinic Mellen Center for Multiple Sclerosis medical director and lead investigator of the CONFIRM study Robert Fox said that the patients who were treated with dimethyl fumarate had less disease activity when compared to patients on placebo, in all the stages of MS in the clinical trials.
"With the efficacy, safety and tolerability measures seen in CONFIRM, this drug provides physicians with an important additional treatment option for their patients across the MS spectrum," Fox added.
Before starting the treatment, Tecfidera patients must have a complete blood count (CBC) to measure lymphocyte counts and is advised to follow up CBC annually with doctor's prescription as the drug may decrease lymphocyte counts in some patients.
The most common side effects noticed in the clinical trials with Tecfidera are diarrhea, nausea and abdominal pain which were noticed to be very low during the course of time.
