Gilenya: First Pill for Multiple Sclerosis Gets FDA OK

Advances in identifying Alzheimer's has not led to better treatment. (CBS)
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(CBS/AP) The FDA has green-lighted the first oral medication for multiple sclerosis.

Gilenya treats the underlying causes of MS, a debilitating nervous system disorder that has traditionally been treated with injectable drugs. The drug is made by Swiss drug giant Novartis.

There is no cure for MS, but steroids and other drugs now on the market can ease its symptoms, which include loss of balance, muscle spasms and other movement problems. All involve daily or regular injections, which doctors say discourage some patients from keeping up with their treatment.

"Many people prefer to take a capsule because they don't like to stick needles into themselves," said Dr. Nick LaRocca, of the National Multiple Sclerosis Society.

Since starting on Gilenya more than two years ago, Seth Morgan, says he has been free of disease relapses. Morgan previously injected himself with a medication every other day.

"People say you get used to the side effects - the discomfort and burning around the injection site - but the fact of the matter is I never did," said Morgan, who worked as a neurologist before being diagnosed with the disease.

MS causes the body's immune system to attack the protective coatings of the brain and spinal cord. Gilenya works to reduce a type of white blood cell that often attacks the nervous system.

The FDA approved another pill-based drug for multiple sclerosis patients earlier this year. However, that drug from Acorda Therapeutics is designed to improve walking ability, rather than treat the underlying disease.

"Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity in MS," said the FDA's director of neurology products, Russell Katz.

The FDA panel that recommended approval of the drug had questsions about its side effects. They said patients should receive their first dose under doctor supervision because of a potentially dangerous drop in pulse rate.

About 2.5 million around the world have MS, including an estimated 400,000 in the U.S.

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