The U.S. Food and Drug Administration (FDA) has announced its approval of Gilenya(TM) (fingolimod), the first oral treatment for relapsing forms of multiple sclerosis (MS).
In patients treated with Gilenya, the relapses were significantly reduced and a delay of the progression of the disease was observed. While it is not a cure for MS, Gilenya can help to slow the build-up of some of the physical problems caused by MS, a major advance for people with this disease.
“Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS, offering patients an alternative to currently available injectable therapies,” said Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.
The drug will be available in 0.5 milligram capsules, at the moment only for patients in the United States. The European Medicines Agency (EMA) regulatory review and other filings worldwide are ongoing. Gilenya is produced by Novartis (Basel, Switzerland)
What is Multiple Sclerosis?
Multiple sclerosis (MS), also known as disseminated sclerosis or encephalomyelitis disseminata, is an autoimmune disease of the nervous system, affecting the brain and the spinal cord. Due to unknown causes, the protective sheath that covers the nerves, called myelin, is attacked and removed by the body’s immune system . This interferes with the communication between brain and body, slowing down or stopping the transference of information. It also results in deterioration of the nerves themselves, a process that is irreversible.
A person with MS can suffer almost any neurological symptom or sign, including blurred vision, weak limbs, tingling sensations, unsteadiness and fatigue. For some people, MS is characterized by periods of relapse and remission, while for others it has a progressive pattern.
There is no known cure for MS. Treatments attempt to return function after an attack, prevent new attacks, and prevent disability. MS medications can have adverse effects or be poorly tolerated, and many patients pursue alternative treatments, despite the lack of supporting scientific study. The prognosis is difficult to predict; it depends on the subtype of the disease, the individual patient’s disease characteristics, the initial symptoms and the degree of disability the person experiences as time advances. Life expectancy of patients is nearly the same as that of the unaffected population.