Novartis Reports Study on Benefit of MS Med in Youth

Novartis (NYSE: NVS) today announced that The New England Journal of Medicine (NEJM) has published full results from the landmark Phase III Gilenya® (fingolimod) PARADIGMS study, the first-ever global, completed, controlled, randomized study specifically designed for children and adolescents (aged 10 to 17) with relapsing forms of multiple sclerosis (RMS). Children and adolescents with MS experience more frequent and often more severe relapses than those seen in adults with MS2.
PARADIGMS met the primary endpoint of significantly reducing the rate of relapses when compared to interferon beta-1a intramuscular injections over a period of up to two years3. The study also met several secondary clinical and imaging endpoints3. While adverse events (AEs) were more common in the interferon beta-1a group, severe AEs were more frequent in Gilenya-treated patients3.
Results from PARADIGMS show that, compared to interferon beta-1a, Gilenya3:

• Significantly reduced annualized relapse rates by 82% (p<0.001) over a period of up to two years compared to interferon beta-1a intramuscular injections
• Significantly reduced the number of new or newly enlarged T2 lesions up to 24 months by 53% (p<0.001). Also, it significantly reduced the average number of gadolinium-enhancing T1 (Gd+) lesions per scan at 24 months by 66.0% (p<0.001). The number and volume of lesions are associated with increased relapse rates
• The safety profile of Gilenya in this study was overall consistent with that seen in previous adult patients
• While more adverse events (AEs) were reported in the interferon beta-1a group, severe AEs were reported at a higher frequency in Gilenya-treated patients
• Cases of seizures were reported in 5.6% of Gilenya-treated patients and 0.9% of interferon beta-1a-treated patients

"I'd like to thank all the children who participated in the PARADIGMS study, and their families, who have helped transform the outlook for pediatric patients living with relapsing MS," 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. "These data, published today, will go a long way in helping to advance knowledge and understanding amongst the MS community of how to evaluate and treat pediatric patients with MS."
"We are proud of this landmark study and appreciate the dedication of the young patients and their families who participated," said Fabrice Chouraqui, President of Novartis Pharmaceuticals Corporation. "This progress was made possible through collaboration with the community, and reflects our steadfast commitment to advancing MS treatment, which has spanned the last two decades."
Gilenya is a well-established treatment for MS in the adult population, having been used to treat more than 255,000 patients globally, in both clinical trials and the post-marketing setting, with approximately 566,000 years of patient experience.
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