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Fingolimod is a sphingosine 1-phosphate (S1P) receptor agonist; it was the first oral disease-modifying agent approved for the treatment of multiple sclerosis (MS). Two double-blind randomised clinical trials (TRANSFORMS and FREEDOMS studies) have shown that in comparison with interferon β-1a or placebo, fingolimod is superior in improving clinical and MRI outcomes in relapsing-remitting MS (RRMS) patients.1 ,2 The FREEDOMS study demonstrated that 0.5-mg fingolimod reduced the annualised relapse rate of RRMS by 55% relative to placebo. On this basis, fingolimod was approved for RRMS treatment in the USA, EU and other countries. To date, more than 77 000 patients have been treated with fingolimod.
In spite of its effectiveness and oral-availability, fingolimod is usually considered as second-line treatment, because it may cause some serious adverse events, particularly cardiovascular related. The European Medicines Agency reported an MS patient who died within 24 h of administration of the first dose of fingolimod. Furthermore, the agency reported …