Novartis secures EC approval for Gilenya in pediatric multiple sclerosis treatment

Novartis has announced that the European Commission has expanded the approval of its multiple sclerosis drug, Gilenya (fingolimod), to include the treatment of children and adolescents aged 10 to 17 years with relapsing-remitting multiple sclerosis. This approval marks Gilenya as the first oral disease-modifying therapy authorized for this younger demographic in Europe.

Pioneering oral therapy for young multiple sclerosis patients

The European Commission’s decision is based on the pivotal Phase III PARADIGMS trial, which was specifically designed to assess the efficacy and safety of Gilenya in pediatric patients. The study demonstrated that Gilenya significantly reduced the annualized relapse rate by 82% compared to interferon beta-1a. Additionally, 85.7% of patients treated with Gilenya remained relapse-free at 24 months, in contrast to 38.8% of those receiving interferon beta-1a. These compelling results underscore Gilenya’s potential to alter the disease trajectory in younger patients.

Addressing a critical unmet need in pediatric multiple sclerosis care

Multiple sclerosis in children and adolescents often presents more aggressively than in adults, leading to frequent relapses and a higher risk of long-term disability. The lack of approved oral disease-modifying therapies for this age group has been a significant gap in treatment options. Novartis’ Gilenya approval addresses this unmet need, offering a convenient oral medication that can improve adherence and quality of life for young patients.

Expert insights on the impact of Gilenya’s approval

Dr. Tanuja Chitnis, Principal Investigator for the PARADIGMS study and Director of the Partners Pediatric Multiple Sclerosis Center at Massachusetts General Hospital, emphasized the importance of this approval. She noted that pediatric multiple sclerosis patients experience more frequent relapses and are more likely to accumulate physical disability at an earlier age than those diagnosed as adults. The availability of an effective oral therapy like Gilenya provides a much-needed treatment option for this vulnerable population.

Novartis’ commitment to advancing multiple sclerosis treatment

Paul Hudson, Chief Executive Officer of Novartis Pharmaceuticals, highlighted the company’s dedication to transforming multiple sclerosis care across all age groups. He stated that early-onset multiple sclerosis can have a devastating impact on children and adolescents’ daily lives, such as going to school and spending time with friends and family. Novartis’ mission is to change the course of multiple sclerosis as they’ve been doing since the treatment’s initial approval in 2011, and they won’t stop until they stop multiple sclerosis. The European Commission’s approval of Gilenya for pediatric use brings them one step closer to reimagining the treatment of multiple sclerosis across all ages.

Implications for the future of pediatric multiple sclerosis management

The European Commission’s approval of Gilenya for children and adolescents represents a significant advancement in multiple sclerosis treatment. It not only provides a new therapeutic option for young patients but also sets a precedent for future research and development in pediatric multiple sclerosis care. As more data emerge from ongoing studies, healthcare providers will be better equipped to tailor treatments to the unique needs of younger patients, ultimately improving outcomes and quality of life.