First Drug for Multiple Sclerosis Nears OK by FDA

The first drug to treat multiple sclerosis is likely to be approved within the month by the Food and Drug Administration, the agency said Monday.

The drug, beta-interferon, was developed by Berlex Laboratories of Richmond, Calif., and will be manufactured by Chiron Corp of Emeryville, Calif. To be sold under the brand name Betaseron, it is the first drug designed to fight the disabling disease, which afflicts an estimated 350,000 Americans.

Multiple sclerosis is a disorder of the central nervous system that destroys muscle. The disease occurs when the body’s immune system attacks the protective myelin sheaths surrounding nerve fibers, in effect short-circuiting the transmission of nerve impulses that control muscle activity.

Victims often experience loss of balance and muscle coordination, blurred vision, slurred speech, difficulty walking and in extreme cases paralysis.

The disease strikes twice as many women as men and two-thirds of all cases develop between the ages of 20 and 40.

“Those of us who have been trying to get through the research and find something good for MS patients are nearly at the finish line,” said Dr. Jeffrey Latts, Berlex’s vice president for clinical research and development. “The prospect of being able to make a new therapeutic agent finally available for MS is very gratifying.”

Studies have demonstrated that patients who take the drug suffer fewer and less severe flare-ups of the disease. The scientific evidence has also suggested, but not proved, that the drug delays the disease’s progression.

Doctors now prescribe steroids and other drugs to reduce flare-ups and ease symptoms.

The drug will be especially valuable for individuals who suffer sudden and unpredictable flare-ups, said Dr. Stephen Reingold, vice president of research and medical programs for the National Multiple Sclerosis Society.

“People who have that form of the disease lead an uncertain existence,” he said. “If you have a medication that can reduce the flare-ups, then you can make a disease of unpredictability somewhat more predictable.”

An FDA advisory committee recommended in March that the agency approve the drug, as well as another one, Tacrine, the first drug to treat Alzheimer’s disease. The FDA has not made its decision on Tacrine, an agency spokesman said.