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Novartis wins US FDA approval for MS drug Gilenya for children ages 10 and older

Novartis AG's Gilenya became the first pill to be approved by the U.S. Food and Drug Administration to treat relapsing multiple sclerosis in children and adolescents ages 10 years and older.

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.

In 2010 the U.S. regulator approved Gilenya, or fingolimod, to treat adults with relapsing multiple sclerosis.

The FDA had already granted priority review and breakthrough therapy designation to the drug for multiple sclerosis in children.