Novartis announces FDA approval of Gilenya®

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

– New approval for Gilenya (fingolimod) addresses a 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)

“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.”…

“We have eagerly anticipated a proven treatment option for younger people living with MS,” said Elin Phillips, President, Pediatric Multiple Sclerosis Alliance. “Until now, there have been no large clinical trials to assess treatment efficacy of disease-modifying therapies in children and adolescents. On behalf of the pediatric community, we would also like to thank the families and the clinical trial patients who made this progress possible.”

(Follow the Novartis link below to read entire article)


Novartis Pharmaceuticals Corporation 

May 11, 2018, 18:35 ET

Leave a Reply