December 11, 2014

Novartis announces results of phase III clinical trial evaluating the safety and efficacy of Gilenya for primary progressive MS

In a statement released on Dec. 1, Novartis announced that a Phase III INFORMS clinical trial investigating the efficacy of the drug Gilenya* (fingolimod) in the treatment of primary progressive MS did not show an improvement in various disability measures compared to placebo. Gilenya is an oral disease-modifying therapy (DMT) that is indicated for the treatment of relapsing-remitting MS, and works by targeting harmful immune cells and keeping them in the lymph nodes where they are unable to enter the central nervous system to attack myelin. In contrast to relapsing-remitting MS, primary progressive MS is characterized by a slow accumulation of disability and an absence of defined relapses and remissions. There are currently no approved treatments for primary progressive MS, which is a discouraging reality for the 10% of people with MS who have this particularly difficult form of the disease. Novartis acknowledged the disappointing nature of the news for people affected by primary progressive MS, but emphasized that they remain “strongly committed to continuing to research new treatment options for patients with MS and other neurological conditions.”

The INFORMS trial was a double-blind, randomized, placebo-controlled, 36-month long study encompassing 969 participants across 148 sites that was designed to evaluate the effect of Gilenya relative to placebo on reducing risk of sustained disability progression based on a combination of measures that included changes to EDSS, assessment of upper limb function, and walking speed, in individuals with primary progressive MS. The study also evaluated the safety and tolerability of the drug. Although the safety profile of the drug was consistent with that seen in people with relapsing-remitting MS, Gilenya nonetheless failed to show a significant difference in improving multiple disability measures in participants with primary progressive MS compared to placebo.

The MS Society is committed to supporting research that will yield answers about the nature of progressive MS and, ultimately, treatments that will slow the accumulation of disability and reverse damage to the nervous system. One example of this commitment is the MS Society’s involvement in the Progressive MS Alliance (PMSA) – an international effort involving health organizations and medical professions from around the world who are working together to address and tackle important needs in progressive MS research and care.

The MS Society will continue to provide updates on progressive MS research and clinical trials as they become available.

*Gilenya® is a registered trademark of Novartis Pharmaceuticals Canada Inc.