According to a story from MD Magazine, the FDA has recently approved the first multiple sclerosis treatment catered to children with the disease. In this instance, the agency did not approve a brand new drug, but instead expanded the indication for an existing one. The drug in question is called fingolimod (marketed as Gilenya). Initially, the therapy was approved for adult patients with the relapsing-remitting variant of the multiple sclerosis.
Multiple sclerosis (MS) is a disease that affects the nervous system. The myelin sheath, an insulating cover that protects nerve cells, is damaged, which affects the ability of nerve cells to communicate. This leads to several symptoms, such as problems with sensation, numbness, muscle spasms, muscle weakness, blurred vision, loss of balance and coordination, fatigue, pain, difficulty speaking and swallowing, and mood disorders such as depression. It is an autoimmune disease, in which the body’s immune system mistakenly attacks part of the body. The overall cause is not understood, but a combination of environmental and genetic factors could play a role. It appears as a relapsing-remitting form, with periods of acute symptoms and periods with no symptoms, or in a long-term, progressive form, with symptoms slowly worsening over time. To learn more about multiple sclerosis, click here.
It is worth noting that Gilenya is still not considered safe to use for patients that are less than ten years old. Multiple sclerosis is a rare illness for children, as most patients begin to experience symptoms between 20 and 40 years of age. Nevertheless, it is projected that anywhere from 8,000 to 10,000 children or adolescents have the disease in the U.S. Young patients tend to experience two or three times as many relapse episodes compared to older adults, making the medical need for a new treatment especially urgent. Gilenya’s new approval will finally offer relief for this group, who have no other treatments that have been officially approved for childhood patients.