Novartis has bagged another approval for its multiple sclerosis pill, Gilenya, this time in Canada.
Health Canada has given the green light to Gilenya (fingolimod), making it the first disease-modifying oral therapy developed for the relapsing-remitting form of MS to get approval in the country. Canada has one of the world's highest rates of MS with an estimated 55,000-75,000 people living with the disease.
Novartis quoted Daniel Selchen, a neurologist from Toronto, as saying that "oral therapies have been greatly anticipated by both patients and physicians who are eager for alternatives to injection and infusion therapies". He added that "with its excellent clinical trial efficacy data, along with convenience, Gilenya is welcome news for those seeking a new option to manage their disease".
This is yet more good news for Novartis which looks as though it could have the oral MS market to itself for some time. Gilenya was recommended for approval in Europe in January and was given the green light by the US Food and Drug Administration last September, while Merck KGaA's rival pill Movectro (cladribine) was turned down by the FDA earlier this month. A marketing application for the latter was withdrawn in Europe in February.