Compared with Copaxone (glatiramer acetate; Teva) injection, treatment with oral Gilenya (fingolimod; Novartis) significantly reduced the annualized relapse rate (ARR) in patients with relapsing remitting multiple sclerosis (RRMS), according to findings from a Phase 3b head-to-head study.

ASSESS (N=1064), a randomized, rater- and dose-blinded study, evaluated the safety and efficacy of once-daily Gilenya 0.25mg and 0.5mg vs once-daily subcutaneous Copaxone 20mg in patients with RRMS. Treatment with Gilenya 0.5mg led to a 40.7% relative reduction in the rate of relapses over a 1-year period vs Copaxone (ARR estimates 0.153 vs 0.258, respectively; P =.0138). Treatment with Gilenya 0.25mg also led to a risk reduction in relapses vs Copaxone but did not reach statistical significance. 

“ASSESS is the first controlled head-to-head study of an MS disease modifying therapy versus Copaxone to show superior efficacy in reducing relapses, a key measure of disease activity and a significant burden for patients,” said Bruce Cree, MD, PhD, MAS, George A. Zimmermann Endowed Professor in Multiple Sclerosis at the University of California San Francisco, and ASSESS Principal Study Investigator. 

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Regarding safety, the profile of both Gilenya doses in the trial was consistent with the established safety characteristics. In general, there were more discontinuations due to adverse events and unsatisfactory treatment effects associated with the Copaxone arm.

Novartis plans to submit the full data upon completion of analyses to future medical meetings and for peer-reviewed publication. 

Gilenya, a sphingosine 1-phosphate receptor modulator, is currently indicated to treat relapsing forms of MS in patients aged ≥10 years. It is supplied as 0.25mg and 0.5mg capsules in 30-count bottles and 7-count blister cards.

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