Novartis has reported positive results from the Phase III PARADIGMS clinical trial of oral Gilenya conducted to treat paediatric multiple sclerosis (MS).
Gilenya is a disease-modifying therapy (DMT) with a reversible lymphocyte redistribution effect that targets the focal and diffuse central nervous system (CNS) damage caused due to the disease.
Results showed a decrease in the rate of relapses (annualised relapse rate) by 82% over a two-year duration when compared with intramuscular injections of interferon beta-1a.
The double-blind, randomised, multi-centre Phase III trial assessed the safety and efficacy of 0.25mg and 0.5mg once-daily dose of Gilenya at 87 sites across 25 countries in 215 people aged between ten and 17 years.
The trial’s primary endpoint was the relapse frequency in patients treated up to 24 months, while the secondary endpoints included number of new or newly enlarged T2 lesions, Gadolinium enhancing T1 lesions, safety, and the pharmacokinetic properties.
Novartis chief medical officer and Drug Development global head Vas Narasimhan said: “There is already substantial evidence that Gilenya is an effective treatment that improves long-term outcomes for adults with relapsing MS.
“We are delighted that PARADIGMS has shown such meaningful benefits for children and adolescents with MS.”
The results further indicated a decrease in the number of new or newly enlarging T2 and Gd-T1 lesions, less brain shrinkage and delayed disability progression with Gilenya.
Furthermore, Gilenya is reported to have demonstrated safety profile consistent with that of previous trials, while more adverse events were observed in the interferon group.