FDA approves fingolimod drug for multiple sclerosis

The first oral medication for multiple sclerosis was approved today by the Food & Drug Administration. Physicians praised the decision to approve the drug, called fingolimod, saying it would give multiple sclerosis patients new options for treatment.

"This is the first pill for multiple sclerosis," said Anthony Reder, MD, Professor of Neurology at the University of Chicago Medical Center. "We have six drugs right now, and they all involve injections. So the convenience alone of a pill is a major change in how we treat MS."

University of Chicago Medical Center was the first institution in the city to enroll patients in a clinical trial for this drug.

Multiple sclerosis, or MS, affects roughly 400,000 Americans and 2.5 million people around the world. A chronic, neurologic disorder, MS can cause issues with walking and movement, fatigue, weakness, pain, and loss of vision. Patients with relapsing-remitting MS suffer from intermittent and unpredictable immune system attacks that can damage the brain, spinal cord, and eyes.

Carol Madey, 43, is part of a Phase III trial comparing fingolimod to placebo at several medical sites, including the University of Chicago Medical Center. She suffered through years of pain, discomfort and misdiagnoses, before being enrolled in the trial in 2007.

"I'd waited years to find out what was wrong with me," Madey says. "I didn't want to wait even longer to treat it."

Madey was diagnosed with MS in 2002, and was originally put on interferon injections. But when her symptoms of extreme fatigue, anxiety, and vision loss began to worsen, she was taken off the treatment and endured the occasional flare-ups. After her second child was born, the symptoms became more severe, and she was enrolled in the clinical trial. Relief was swift and substantial.

"I noticed the results immediately. I had more energy and less pain," she said. Within a month Madey was returning to normal. "As my husband likes to say, 'it gave me back my wife.'"

Fingolimod, a drug modified from a fungus originally found in Asian wasps, prevents autoimmune attacks by trapping white blood cells in the body's lymph nodes. Two large Phase III clinical studies published in February found that fingolimod was at least twice as effective in preventing MS attacks when compared to placebo or current treatments.

Research on additional uses for fingolimod continues at the University of Chicago, including a new clinical trial in patients with progressive MS, for which there are no available treatments. With fingolimod adding to the recent boom of new MS therapies, and with a number of clinical trials for new therapies in progress, patients should be sure to seek out an experienced MS center for their care.

"Multiple sclerosis therapies are becoming very complex," Reder said. "To do justice to all of the effective drugs out there you need to talk to someone who has expertise with all of these therapies."