The approval was based on the clinical trial program submitted to date for a new MS drug, and included data from clinical studies showing efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI), a measure of disease activity.
Gilenya, licensed from Mitsubishi Tanabe Pharma, is the first in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators.
The mechanism of Gilenya is thought to work by reducing the immune system’s attack on the central nervous system (CNS) by retaining certain white blood cells (lymphocytes) in the lymph nodes.
The white blood cell retention is reversible if Gilenya treatment is stopped.