Novartis announces FDA approval of Gilenya® as the first disease-modifying therapy for pediatric relapsing multiple sclerosis

 New approval for Gilenya (fingolimod) addresses strong unmet need for younger patients, who often experience more frequent relapses than adults with multiple sclerosis (MS)(1)– In a landmark controlled Phase III study of children and adolescents (ages 10 to less than 18) with relapsing forms of MS (RMS), Gilenya reduced the annualized relapse rate by approximately 82% vs. interferon beta-1a injections (p< 0.001)(2)– Gilenya is the most prescribed oral once-daily MS disease-modifying treatment, with a global exposure of more than 231,000 patients since its initial approval for adults with RMS(3)

 

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Novartis Pharmaceuticals Corporation 

May 11, 2018, 18:35 ET

EAST HANOVER, N.J., May 11, 2018 /PRNewswire/ — Novartis today announced that the US Food and Drug Administration (FDA) has approved Gilenya® (fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis, making it the first disease-modifying therapy indicated for these patients2.

 

This approval expands the age range for Gilenya, which was previously approved for patients aged 18 years and older with RMS. Gilenya was granted Breakthrough Therapy designation by the FDA in December of 2017 for this pediatric indication.

 

“We now finally have an FDA-approved treatment for children and adolescents with relapsing MS,” said Dr. Brenda Banwell, Chief of the Division of Neurology at Children’s Hospital of Philadelphia, who served as co-Principal investigator of the pivotal study that supported the pediatric approval. “Repeated relapses are more common in young people with MS than in adults, so this is heartening news for patients and their families.”