Novartis new MS treatment receives Notice of Compliance in Canada

Novartis Pharmaceuticals Canada Inc. announced today that its new MS treatment, Gilenya™ (fingolimod), has received Notice of Compliance in Canada. Gilenya™ (fingolimod) is the first disease modifying oral therapy developed for the relapsing-remitting form of multiple sclerosis (MS) which is the most common type of the disease in adults. Unlike current therapies which all require daily or regular injections or infusions, Gilenya offers simple once daily oral dosing (0.5 mg) in a capsule, providing an efficacious and convenient treatment method for a complex and lifelong illness. Gilenya is approved for use in patients who have tried one or more MS therapies, but are unresponsive or intolerant to them.

"The approval of Gilenya is a significant milestone for the Canadian MS community," says Dr. Daniel Selchen, a neurologist from Toronto, Ontario. "Oral therapies have been greatly anticipated by both patients and physicians who are eager for alternatives to injection and infusion therapies.  With its excellent clinical trial efficacy data, along with convenience, Gilenya is welcome news for those seeking a new option to manage their disease."  

"I feel like I have my life back again," says Ms. Himani Ediriweera, a 39 year old from Toronto, who was diagnosed with MS over six years ago and has been on Gilenya for the last four years since participating in a clinical trial. "I have a fear of needles and hate the limitations my disease places on my lifestyle. I have gone from having five to six relapses per year to one or two since I started Gilenya - MS no longer has control over my life."

Data demonstrates efficacy
The 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 30µg), 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 works
Gilenya 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.