Multiple Sclerosis Oral Treatment Approved in Canada

Author: Novartis Pharmaceuticals Canada Inc.
Published: 2011/03/10 - Updated: 2016/06/13
Peer-Reviewed: N/A
Contents: Summary - Main - Related Publications

Synopsis: Gilenya (fingolimod) is the first disease modifying oral therapy developed for the relapsing-remitting form of multiple sclerosis (MS).

First oral treatment for people with multiple sclerosis approved in Canada - Shown to significantly reduce relapses and slow disease progression.

Main Digest

First oral treatment for people with multiple sclerosis approved in Canada - Shown to significantly reduce relapses and slow disease progression.

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 30mg), 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.

About MS

Canada has one of the world's highest rates of MS with an estimated 55,000 - 75,000 Canadians living with the disease. Typically, MS strikes in early adulthood between the ages of 20 and 50 and women are more than three times more likely to develop MS than men.

MS is an unpredictable, often disabling disease of the CNS. It occurs because the body attacks the myelin, a protective covering wrapped around the nerves of the CNS, causing lesions or scars in the CNS as demyelination occurs.

The cause of MS is still unknown, though current research increasingly points to a complex interplay of environmental and possibly genetic risk factors. The most common form of the disease, relapsing-remitting MS (RRMS) describes a type of MS characterized by unpredictable, but clearly defined episodes during which new symptoms appear, or existing ones get worse. These 'episodes' are also known as attacks, relapses, exacerbations, or flare-ups. The hallmark of RRMS is the recovery, or 'remission', that occurs between attacks.

Safety information

The most common side effects are headache, liver enzyme elevations, influenza, diarrhea, back pain, and cough. Other Gilenya-related side effects include reversible, generally asymptomatic, heart rate reduction upon treatment initiation, mild blood pressure increase, macular edema, and mild effect on lung function. Gilenya also lowers the number of white blood cells and may therefore increase the risk of infections. Patients should contact their doctor if they experience any changes in their vision, if they have trouble breathing, if they have symptoms of infection, or if they have abnormal dark urine.

Gilenya can cause a patient's heart rate to slow down, especially after the first dose. The patients will be under medical supervision for the first six hours after the first dose to see if they have any serious side effects, including irregular heart beat. Slow heart rate usually returns to normal within one month. Patients should call their doctor if at any time they experience dizziness, tiredness or a slow or irregular heart rate.

Gilenya may cause harm to an unborn child. Women should talk to their doctor if they are pregnant or planning to become pregnant. Women who become pregnant while on Gilenya should inform their doctor right away.

Patients should tell their doctor about all their medical conditions, including if they have heart problems, are unable to fight infections, have eye problems, diabetes, breathing difficulties, liver or kidney problems. Patients should also inform their doctor about all the medicines they take. For additional safety information, please refer to the Product Monograph on

Gilenya Patient Support Program

Novartis provides patients and their families with a Gilenya Patient Support Program, which is designed to help optimize outcomes among those with MS. It provides patients with a wealth of up-to-date resources, including patient education, access to the personalized services of a trained nurse and access to reimbursement support services for all patients requiring Gilenya. For more information, patients and their loved ones should contact their treating physician.

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