Novartis: EU Approves Gilenya To Treat MS In Children, Adolescents - Quick Facts

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(RTTNews.com) - Swiss drug major Novartis AG ( NVS ) announced Thursday that the European Commission has approved Gilenya (fingolimod) for the treatment of children and adolescents 10 to 17 years old with relapsing-remitting forms of multiple sclerosis or RRMS.

The European market authorization makes Gilenya the first and only oral disease-modifying treatment for children and adolescents based on clinical Phase III data.

Multiple sclerosis is a chronic disorder of the central nervous system that disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss.

The EC's approval is based on the PARADIGMS trial, a landmark Phase III clinical study in MS, specifically designed for children and adolescents 10 to 17 years old. Results from the double-blind, randomized, multi-center study of Gilenya vs. interferon beta-1a show that Gilenya significantly reduced the annualized relapse rates.

The full PARADIGMS data were published in The New England Journal of Medicine in September 2018.

The 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 the US and Europe. Gilenya received FDA approval for the treatment of children and adolescents 10 years of age and older with MS on May 11, 2018.

Read the original article on RTTNews (http://www.rttnews.com/2958554/novartis-eu-approves-gilenya-to-treat-ms-in-children-adolescents-quick-facts.aspx)

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Referenced Symbols: NVS

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