www.fdanews.com/articles/192111-novartis-ms-drug-gilenya-given-greenlight-in-china
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Novartis’ MS Drug Gilenya Given Greenlight in China
July 24, 2019
The Chinese National Medical Products Administration (NMPA) has granted Novartis approval for its multiple sclerosis (MS) drug Gilenya (fingolimod).
The drug has been approved for treating relapsing forms of MS (RMS) in adults and children aged 10 years and older. There are approximately 30,000 MS patients in China and it is characterized as a rare disease in the country.
The pharma giant’s MS treatment is the third most prescribed MS disease modifying treatment in the world. Another one of its RMS treatments, Mayzent (siponimod), received FDA approval in March and will soon undergo regulatory review in China.