Reportedly, the MAA submission and Canadian NDS are based on a comprehensive development program including results from two Phase III, randomised, double-blind, placebo-controlled studies. These studies demonstrated the efficacy of Fampridine-PR tablets in improving walking ability in patients with relapsing remitting, secondary progressive, progressive relapsing, and primary progressive MS.
In the two Phase III clinical trials, a greater portion of Fampridine-PR-treated patients had a consistent improvement in walking speed when compared to placebo. The increased response rate of the Fampridine-PR group was observed across all types of MS included in the studies.
Furthermore, the Fampridine-PR treated subjects who had consistent improvement in the two studies experienced an average increase in walking speed of 25.2% and 24.7% compared to 4.7% and 7.7%, respectively, for the entire placebo group.
The majority of the study participants in these trials were using immunomodulatory drugs, including interferons, glatiramer acetate, and natalizumab; however the magnitude of improvement in walking ability was independent of concomitant therapy.
Alfred Sandrock, senior vice president of neurology research and development at Biogen, said: “Walking impairment has a significant impact on the lives of many people living with MS. Fampridine-PR tablets may offer a novel approach to address this debilitating aspect of the disease by improving the walking ability of MS patients. We look forward to working with regulators to make this therapy available to people with MS in Europe and Canada.”