Approval of Novartis’ Gilenya expanded to treat multiple sclerosis in paediatric patients

Gilenya, which the FDA first approved in adults back in 2010, has had its approval expanded to treat relapsing multiple sclerosis (MS) in children and adolescents over the age of 10 years. This is the first FDA approval of a drug to treat MS in paediatric patients.

“For the first time, we have an FDA-approved treatment specifically for children and adolescents with multiple sclerosis,” said Dr Billy Dunn, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can have a profound impact on a child’s life. This approval represents an important and needed advance in the care of paediatric patients with multiple sclerosis.”

Multiple Sclerosis is a chronic, inflammatory, autoimmune disease that affects the central nervous system by disrupting communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For the majority of those with MS, episodes of worsening function and appearance of new symptoms, called relapses or flare-ups, are initially followed by recovery periods. Over time, recovery may be incomplete, leading to progressive decline in function and increased disability. Most patients with MS experience their first symptoms, such as vision problems or muscle weakness, between the ages of 20 to 40. Approximately 2-5% of people with MS have symptom onset before age 18 and estimates suggest that 8,000 to 10,000 children and adolescents in the U.S. have MS.

The clinical trial evaluating the effectiveness of Gilenya in treating paediatric patients with MS included 214 evaluated patients aged 10 to 17 and compared Gilenya to another MS drug, interferon beta-1a. In the study, 86% of patients receiving Gilenya remained relapse-free after 24 months of treatment, compared to 46% of those receiving interferon beta-1a.

The side effects of Gilenya in paediatric trial participants were similar to those seen in adults. The most common side effects were a headache, liver enzyme elevation, diarrhoea, cough, flu, sinusitis, back pain, abdominal pain and pain in extremities.

Source: European Pharmaceutical Review

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