Novartis said Gilenya prevents the white blood cells from reaching the CNS, where they could potentially attack the protective covering around the nerve fibers, resulting in less inflammatory damage to the nerve cells.
The positive opinion was based on positive data from clinical studies evaluating the MS drug which showed efficacy in the reduction of relapses, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI), a measure of disease activity.
Novartis Pharmaceuticals Division head David Epstein said they are pleased with CHMP’s recommendation because it means patients in Europe with highly active relapsing-remitting MS could soon benefit from Gilenya’s significant efficacy in a once-daily capsule.