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May 15, 2018

FDA approves Novartis’ Gilenya to treat paediatric multiple sclerosis

The US Food and Drug Administration (FDA) has approved Novartis’ Gilenya (fingolimod) drug for the treatment of relapsing forms of multiple sclerosis (RMS) in children and adolescents.

The US Food and Drug Administration (FDA) has approved Novartis’ Gilenya (fingolimod) drug for the treatment of relapsing forms of multiple sclerosis (RMS) in children and adolescents.

Gilenya is an oral disease-modifying therapy (DMT) that has a reversible lymphocyte redistribution effect targeting both focal and diffuse central nervous system damage caused by MS.

The drug is said to be the first DMT indicated for patients aged ten to 18. This age group is known to experience frequent relapses and brain lesions when compared to adults.

Novartis Pharmaceuticals CEO Paul Hudson said: “Since revolutionising the treatment of relapsing MS as the first oral disease-modifying therapy, Gilenya has become an important mainstay of treatment for adult patients.

“We are delighted this has led to a long-awaited, specifically-approved treatment option for young patients.”

“Today’s announcement is a result of our pioneering approach and ongoing commitment to advancing care for all individuals living with MS, and we are delighted this has led to a long-awaited, specifically-approved treatment option for young patients.”

The FDA decision follows a review of data from a  Phase III clinical trial that compared the safety and efficacy of Gilenya with interferon beta-1a intramuscular injections in 215 subjects.

During the double-blind, randomised, multi-centre trial, Gilenya demonstrated an 82% decrease in the rate of relapses over two years. The drug’s safety profile was consistent with that of prior trials performed in adults.

Gilenya was previously approved in the US for RMS patients aged 18 and above, and secured FDA breakthrough therapy designation for the paediatric indication in December last year.

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