(RxWiki News) Pharmaceutical company Novartis AG's multiple sclerosis (MS) drug, Gilenya, has been approved for use in the United States and now Europe to treat relapsing-remitting forms of the disease.
Gilenya slows MS and helps alleviate symptoms associated with the autoimmune disease. The drug won approval from the U.S. Department of Food and Drug Administration (FDA) in September, and this month the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use recommended the drug for use. The European Commission usually follows the panel's advice.
Meanwhile, a rival drug known as cladribine, manufactured by Merck, has not been approved in the United States (the FDA extended a review of the drug in November by three months.) The EMA determined cladribine's risks outweighed its benefits.
Gilenya keeps lymphocytes, a type of white blood cell that attacks the immune system in MS, from being released. These white blood cells damage the myelin sheath that coats nerves, causing inflammation. When this inflammation occurs, a host of symptoms can appear, ranging from mildly annoying to crippling. These symptoms can include loss of balance, muscle spasms, numbness or abnormal sensation in any part of the body, tremor, weakness, vision loss, urinary incontinence, dizziness and sexual disturbances.
