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Novartis approved for oral MS medication in Canada
March 10th, 2011
DORVAL, Quebec – Novartis has been cleared to market the first oral treatment for multiple sclerosis (MS) in Canada.
Novartis Pharmaceuticals Canada Inc. said Thursday that it has received Notice of Compliance in Canada for Gilenya (fingolimod), the first disease-modifying oral therapy developed for the relapsing-remitting form of MS, the most common type of the disease in adults.
Unlike current therapies that require daily or regular injections or infusions, Novartis explained, Gilenya offers a once-daily oral dose (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.
Plans call for Gilenya to become available in Canadian pharmacies starting April 1.
Canada has one of the world's highest rates of MS, with an estimated 55,000 to 75,000 people living with the disease, according to Novartis. 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.
"The approval of Gilenya is a significant milestone for the Canadian MS community," Dr. Daniel Selchen, a neurologist from Toronto, said in a statement released by Novartis. "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."