US approves first oral pill for multiple sclerosis
The US Food and Drug Administration announced Wednesday it has approved the first oral drug to treat the most common form of multiple sclerosis (MS).
Gilenya, or fingolimod, is the first in a new class of medications that help block certain blood cells from migrating to the brain and spinal cord, which could help reduce the severity of MS in patients with relapsing forms of the disease, according to the FDA.
The approval is considered a valuable step forward for MS patients due to the frequent needle injections needed for treatment of the complex neurological condition. Some 2.5 million people are affected worldwide, including 400,000 in the United States.
"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," Russell Katz, director of the neurology products at the FDA's Center for Drug Evaluation and Research, said in a statement.
MS can be unpredictable, with symptoms varying dramatically from one person to another. They can be mild, such as numbness in limbs, or severe, including paralysis and blindness.
The FDA said Gilenya, produced by Swiss pharmaceutical giant Novartis, carries a risk of side effects, including a decrease in heart rate for new users of the drug, as well as headache, flu, diarrhea and back pain.
© 2010 AFP