Efficacy

Tecfidera (Dimethyl Fumarate) for Multiple Sclerosis

Tecfidera (dimethyl fumarate) is an oral medication approved by the Food and Drug Administration (FDA) for the treatment of relapsing forms of multiple sclerosis (MS), which include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The efficacy of Tecfidera in treating MS has been demonstrated in a number of clinical trials. These studies have shown that Tecfidera can reduce the rate of relapses, slow the progression of disability, and decrease the number of MS lesions as detected by MRI scans. The exact mechanism of action of dimethyl fumarate in MS is not fully understood, but it is thought to modulate the immune response and exert neuroprotective effects.

In pivotal Phase III clinical trials, such as the DEFINE and CONFIRM studies, Tecfidera significantly reduced the annual relapse rate by approximately 50% compared to placebo. Additionally, it was shown to reduce the risk of progression of disability by up to 38% compared to placebo. These trials also reported a reduction in the number of new or enlarging T2-hyperintense lesions and gadolinium-enhancing lesions on MRI, which are indicative of disease activity in MS patients.

Fampyra (Fampridine) for Multiple Sclerosis

Fampyra (fampridine), known as Ampyra in the United States, is another medication used in the management of MS. It is specifically approved for the improvement of walking in patients with MS. This was demonstrated by an increase in walking speed in clinical trials. Fampridine is a potassium channel blocker that is thought to improve nerve signal conduction in damaged nerves, which can be beneficial for some individuals with MS.

The efficacy of Fampyra in improving walking speed in MS patients was shown in two Phase III clinical trials. These trials measured the walking speed of participants on a timed 25-foot walk (T25-FW). The results indicated that a significantly greater proportion of patients taking Fampyra had a consistent improvement in their walking speed compared to those taking a placebo. It is important to note that the response to Fampyra is variable, and not all patients with MS may experience an improvement in walking ability. Additionally, the benefits of Fampyra on other aspects of MS, such as relapse rate or disability progression, have not been established.