Cervical spine MRI with enhancement showing multiple sclerosis.
Credit: Wikimedia
WASHINGTON: The U.S. Food and Drug Administration announced 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, who have endured frequent needle injections needed for treatment of the complex neurological condition.
First alternative to injections
Some 2.5 million people have MS 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,” Russell Katz, director of the neurology products at the FDA's Centre for Drug Evaluation and Research, said in a statement.
“It offers patients an alternative to currently available injectable therapies."
M.S. an unpredictable disease
MS is a chronic and often disabling disease which attacks myelin, the fatty substances that surround and protect the nerve fibres in the central nervous system.
The disease can be unpredictable, with symptoms varying dramatically from one person to another.
They can be mild, such as fatigue, numbness in limbs, and balance problems, or severe, including paralysis and blindness.
Largest-ever clinical trial program
The cause of MS is still not known, but researchers believe it is an autoimmune disease which can be affected by genetic and environmental factors, according to the U.S.-based National Multiple Sclerosis Society (NMSS).
Gilenya's maker, Swiss pharmaceutical giant Novartis, hailed the FDA approval, which the company said was based on the largest-ever clinical trial program submitted to the FDA for a new MS drug.
"We are proud to have worked successfully with the MS community toward a shared goal of bringing a novel efficacious treatment to people with relapsing forms of MS," said Trevor Mundel, global head of development at Novartis Pharma AG.
