Abstract
Fingolimod was approved in Europe until the 2nd line of treatment for relapsing multiple sclerosis in children and adult patients. It is also recommended in the first line for a highly active form of multiple sclerosis.
The results of phase 2, phase 3 (TRANSFORMS, FREEDOMS) and phase 3b (LONGTERMS) clinical trials are presented, which evaluate longitudinal efficacy, safety and MR data of fingolimod in real clinical practice. The fundamental benefit of long-term collection of clinical data from real clinical practice is highlighted, which complemented data on the efficacy and safety of fingolimod and the reduction of the most common adverse reactions of randomized multicentre studies - lymphopenie, liver enzyme elevation, basal cellular carcinoma.
The results of the PARADIGMS clinical study demonstrated the efficacy and safety of fingolimod for the pediatric MS population from the age of 10 years.