Novartis announced results from the Phase III PARADIGMS study, investigating the safety and efficacy of fingolimod vs. interferon beta-1a, in children and adolescents (ages 10 to <18) with relapsing multiple sclerosis (MS). Treatment with oral fingolimod resulted in an 82% reduction in the rate of relapses (annualized relapse rate) in this patient population over a period of up to two years, compared to interferon beta-1a intramuscular injections (p <0.001)1. PARADIGMS is the first completed randomized, controlled clinical trial specifically designed for children and adolescents with relapsing MS. The results have been presented at the 7th Joint European and Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) meeting on October 28, 2017 in Paris, France.

"There are currently no FDA-approved MS therapies for the pediatric population," said Dr. Tanuja Chitnis, Principal Investigator for PARADIGMS and Director of the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston, US, and Scientist, Ann Romney Center, Brigham and Women's Hospital, Boston, US. "We are encouraged by the reduction in the annualized relapse rate we've seen with fingolimod in this study. PARADIGMS was designed specifically for pediatric patients, who oftentimes have more frequent relapses than adults with early MS."

Additional data from the study demonstrated:

Secondary endpoints showed a significant reduction in the number of new / newly enlarging T2 lesions and Gd-T1 lesions in the brain in fingolimod-treated patients compared to those treated with interferon beta-1a, as measured by magnetic resonance imaging (MRI)1.

The safety profile of fingolimod in this study was overall consistent with that seen in previous clinical trials in adults. In this study, while more adverse events (AEs) were reported in the interferon beta-1a group, severe AEs were reported at a higher frequency in fingolimod-treated patients3.

An exploratory analysis found individuals treated with fingolimod had significantly less brain volume loss (measured by MRI), compared to those treated with interferon beta-1a1.

"Gilenya has been shown to improve outcomes for adults with relapsing MS. We're proud of having completed this head-to-head trial in children and adolescents with relapsing MS and are encouraged by the findings," said Fabrice Chouraqui, President of Novartis Pharmaceuticals Corporation. "The study reflects our ongoing commitment to the MS community."

Fingolimod, also known as Gilenya® in the US, is approved to treat relapsing forms of MS in adults. Gilenya is not currently approved for children and adolescents with relapsing MS. Novartis is working on submission with health authorities worldwide for pediatric patients.