Multiple sclerosis causes the immune system to attack the insulating tissue around nerve fibers, called myelin, leading to scars and inflammation. This stops nerve cells from sending signals, leading to symptoms such as blurred vision and muscle weakness.

Fingolimod is an oral medication used for treating multiple sclerosis (MS). Its mechanism of action isstill unknown, although it may work by reducing the number of circulating lymphocytes (a type of white blood cell), leading to reduced migration of white blood cells into the central nervous system. White blood cells cause inflammation and destruction of nerves in patients with MS.

On September 22, 2010 the US Food and Drug Administration (FDA) announced approval of fingolimod (Gilenya, Novartis), the first of the long-anticipated oral treatments for multiple sclerosis (MS). Given orally, fingolimod acts as a superagonist to sphingosine-1-phosphate receptors on the surface of thymocytes and lymphocytes, reducing the overall number of circulating lymphocytes available to mount an autoimmune reaction to the myelin sheath surrounding axons in MS.

Although the trials so far have shown fingolimod to be well tolerated, the side effects that have occurred include headache, upper respiratory tract infection, shortness of breath, diarrhoea and nausea. In addition, increased levels of liver enzymes and blood pressure have been observed although these are generally mild.

The approval is considered a valuable step forward for MS patients, who have tolerated frequent needle injections needed for treatment of the complex neurological condition.