November 29, 2018 / 6:25 AM / 16 days ago

BRIEF-Novartis - Eu Approval Of Gilenya For Children And Adolescents With MS

Nov 29 (Reuters) - Novartis AG:

* ANNOUNCES EU APPROVAL OF GILENYA® FOR CHILDREN AND ADOLESCENTS WITH MS, MAKING IT FIRST AND ONLY ORAL DISEASE-MODIFYING TREATMENT FOR THESE PATIENTS IN EUROPE

* APPROVAL BASED ON LANDMARK PARADIGMS STUDY SHOWING GILENYA (FINGOLIMOD) SIGNIFICANTLY REDUCED RELAPSE RATES BY 82% VERSUS INTERFERON BETA-1A; ADDITIONALLY, 85.7% OF GILENYA PATIENTS WERE RELAPSE-FREE AT TWO YEARS

* EC’S APPROVAL IS BASED ON PARADIGMS TRIAL, A LANDMARK PHASE III CLINICAL STUDY IN MS, SPECIFICALLY DESIGNED FOR CHILDREN AND ADOLESCENTS 10 TO 17 YEARS OLD

* EC DECISION IS APPLICABLE TO ALL 28 EUROPEAN UNION MEMBER STATES PLUS ICELAND, NORWAY AND LIECHTENSTEIN

* GILENYA WAS INITIALLY APPROVED FOR ADULTS AGED 18 YEARS AND OLDER WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS IN US AND EUROPE Source text for Eikon: Further company coverage: (Berlin Speed Desk)

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