The US Food and Drug Administration (FDA) has granted approval to Gilenya (fingolimod) as a treatment for children and adolescents with multiple sclerosis (MS). The Novartis medication is the first drug approved by the FDA for treatment of pediatric patients with MS.
Gilenya first gained FDA approval as a treatment for adult patients with relapsing MS in 2010. Efficacy of the drug in pediatric patients was demonstrated in a clinical trial involving 214 patients between the ages of ten and 17. A comparison was made between those treated with Gilenya, and patients treated with another MS drug, interferon beta-1a.
MS is an autoimmune disease affecting the brain and spinal cord. There is no cure and treatment focuses on management of symptoms and preventing further progression of the condition. It affects more than 400,000 people in the United States, according to figures from the Multiple Sclerosis Foundation and studies suggest between three and five percent of individuals diagnosed with the condition experience disease onset before the age of 16.
Kathy Costello, MS, ANP-BC, MSCN, associate vice-president of Healthcare Access at the National MS Society, commented: “As the first therapy specifically approved to treat children and teens with MS, this is a major milestone.”
The FDA granted Gilenya Priority Review and Breakthrough therapy designation for its indication for use in children and adolescents with MS. The clinical trials found the side effects of the drug in pediatric patients were comparable to those experienced by adults with the condition. The most common side effects were headaches, elevation of liver enzyme levels, diarrhea, cough, flu, sinusitis, back pain, abdominal pain and pain in extremities.
Currently, clinical trials are underway to evaluate the use of other MS drugs in pediatric patients. Among the drugs being studied are Tecfidera (dimethyl fumarate) and Aubagio (teriflunomide). In March this year, pharmaceutical firms Biogen and Abbvie announced a voluntary withdrawal of their MS drug Zinbryta (daclizumab) from the US market.
For more information on Gilenya, visit: https://gilenya.com/index.jsp
