The FDA has approved Gilenya (fingolimod capsules, from Novartis), a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. This approval was based on study data which demonstrated that Gilenya reduced relapses by 52% (p<0.001) at one year compared with interferon beta-1a IM (Avonex, from Biogen Idec). Gilenya also reduced disease activity as measured by the number of new and newly enlarged T2 lesions on MRI scans compared to interferon beta-1a IM (1.6 vs 2.6, respectively, p=0.002) at one year.
Data from a two-year placebo-controlled study showed a reduction in relapse rate (54% reduction, p<0.001) and risk of disability progression among Gilenya patients (30% reduction confirmed at 3-month follow-up visit, p=0.02). In both studies, treatment with Gilenya also resulted in statistically significant reductions in brain lesion activity as measured by MRI.
Gilenya will be available in early October in a 0.5mg dosage strength.