Phase IV data for Gilenya (fingolimod) shows high patient retention rate in multiple sclerosis- Novartis

Novartis announced data from a randomized, prospective, Phase IV, open-label study that demonstrated patient retention rate with Gilenya (fingolimod) was significantly higher at 12 months than with injectable disease-modifying therapies in patients with early relapsing-remitting multiple sclerosis (RRMS), 81% vs. 29% respectively. Compared to injectable disease-modifying therapies, Gilenya also improved clinical and MRI outcomes and was associated with greater patient satisfaction.

The Prospective, Randomized, active-controlled, open-label study to Evaluate patient retention of Fingolimod versus approved first-line disease-modifying therapies in adults with Relapsing-remitting Multiple Sclerosis (PREFERMS) was the first large randomized study of treatment retention comparing fingolimod 0.5 mg with injectable disease-modifying therapies (interferon beta or glatiramer acetate) over a period of 12-months. Safety outcomes for all treatments were consistent with the respective US Prescribing Information. The findings were presented for the first time in the US at the 2016 Annual Meeting of the Consortium of Multiple Sclerosis Centers.

Comment: Gilenya, a sphingosine 1-phosphate receptor (S1PR) modulator, was the first oral treatment for multiple sclerosis, a condition that has been usually treated by injection or infusion. The drug has been effective in reducing the number of relapses and is the only approved treatment shown to consistently decrease brain volume loss. However concerns have been expressed about cardiovascular side effects of Gilenya which have required monitoring and Novartis has added to the label a caution that potential Gilenya patients should first take an ECG. An FDA alert highlighted a patient that developed the often fatal brain infection- progressive multifocal leukoencephalopathy. Gilenya was accepted by NICE on the basis of data confirming its benefit for patients with" highly active disease".