Novartis new MS treatment receives Notice of Compliance in Canada

September 07, 2017

Data demonstrates efficacyThe approval of Gilenya was based on the largest clinical trial program ever submitted to Health Canada for a new MS drug, and included studies demonstrating significant efficacy in reducing relapses. Compared to a current standard of treatment (Avonex?, interferon beta-1a IM 30?g), Gilenya showed superior efficacy over one year by reducing relapses by 52%. The submission also included a two-year placebo controlled study, which demonstrated the significant efficacy of Gilenya in delaying disability progression. In both submitted studies, treatment with the medication also resulted in a statistically significant reduction in the number and volume of active brain lesions (a measure of disease activity) in people with the relapsing-remitting form of MS.

Gilenya has a well-studied safety and tolerability profile. It has been studied in over 4,000 MS patients around the world. Some of these patients are in their seventh year of treatment with Gilenya. To date, there are over 8,000 years of patient exposure data on Gilenya.

How Gilenya worksGilenya is the first in a new class of medications called sphingosine 1-phosphate receptor (S1PR) modulators. It is thought to reduce the frequency of MS relapses (when new symptoms appear, or existing ones get worse) by retaining certain white blood cells (lymphocytes) in the lymph nodes. This prevents the white blood cells from reaching the central nervous system (CNS) and potentially attacking myelin, the fatty substance that insulates nerves and helps them transmit impulses between the brain and the body. Gilenya does not cure MS, but it can help delay the progression of the disease.

Gilenya will be available in pharmacies as of April 1, 2011.