16 May 2018 - - Silver Spring, Maryland-based public health protection agency The US Food and Drug Administration (FDA) has approved Gilenya (fingolimod) to treat relapsing multiple sclerosis in children and adolescents age 10 years and older, the company said.
This is the first FDA approval of a drug to treat MS in pediatric patients. The FDA granted the approval of Gilenya to Novartis.
The clinical trial evaluating the effectiveness of Gilenya in treating pediatric 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 pediatric trial participants were similar to those seen in adults. The most common side effects were headache, liver enzyme elevation, diarrhea, cough, flu, sinusitis, back pain, abdominal pain and pain in extremities.
The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.