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A decade after US approval, Novartis' Gilenya scores marketing authorisation in China for relapsing multiple sclerosis

Published on 19/07/19 at 11:09am

Novartis has revealed that its disease modifying drug Gilenya (fingolimod) has secured approval in China for the treatment of relapsing forms of multiple sclerosis (RMS), almost a decade after it originally received marketing authorisation in the US.

The Chinese National Medicinal Products Administration (NMPA) approved the drug’s use in patients over the age of 10.

In China, MS is treated as a rare disease, and it is estimated that around 30,000 patients are affected by the condition in the country.  Despite being on the market for a decade, the drug remains Novartis’ second-highest revenue-generating product, making $825 million in the second quarter.

“It is exciting news for MS patients in China that Gilenya has received fast approval. The approval of Gilenya and the upcoming regulatory review for Mayzent demonstrate our commitment to Chinese patients,” remarked Marie-France Tschudin, President of Novartis Pharmaceuticals. “We are proud that Gilenya already demonstrated its benefits to over 283,000 MS patients worldwide. We are committed to bringing innovation to China with our key brands Entresto, Cosentyx and now Gilenya.”

Ingrid Zhang, President of Novartis Pharmaceuticals China, also commented: “I am delighted that we can now offer Gilenya to doctors and patients in China. There is a considerable need for MS treatments in China and we strive to bring clinical benefit to many patients with multiple sclerosis and improve their quality of life.”

Matt Fellows

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