The European regulatory authority has approved Novartis’ oral multiple sclerosis (MS) therapy Gilenya® (fingolimod). EU approval covers use of the drug as a disease-modifying therapy for patients who exhibit highly active relapsing-remitting multiple sclerosis (RRMS) despite treatment with beta interferon, or for patients with rapidly evolving severe RRMS. Russia was the first country to approve the drug, in September 2010, just a couple of weeks before FDA approval was also granted. Approval in Switzerland and Australia was achieved in January 2011.
“Gilenya has been in clinical development for MS since 2003,” notes David Epstein, division head of Novartis Pharmaceuticals. “Today’s announcement marks another major regulatory approval and we are pleased that Gilenya will become available to more eligible MS patients.”
Gilenya is a sphingosine 1-phosphate receptor (S1PR) modulator that is thought to work by retaining white blood cells in the lymph nodes, thus preventing them from migrating into the brain and spinal cord where they cause damage. EU approval was based on trial data demonstrating that Gilenya reduced relapses by 52% at one year, compared with therapy using intramuscular interferon beta-1a (Biogen Idec’s Avonex®). Results from a two-year trial in addition showed that patients treated using Gilenya had a 30% lower risk of disability progression compared with those treated using placebo. MRI evaluation has also confirmed Gilenya therapy leads to statistically significant reductions in brain lesion activity, Novartis notes.