An estimated 350,000 Americans suffer from multiple sclerosis, a crippling, and often unpredictable, immune system disease that causes a breakdown of the myelin sheath, the protective insulation that surrounds the nerve fibers of the central nervous system. Its symptoms vary in severity from patient to patient, but they include excessive weakness, impaired vision, loss of balance and muscle coordination, loss of cognitive ability and, in the most severe cases, paralysis. In its early stage, the disease typically takes a course of remissions and relapses, in which patients experience periodic flare-ups, or relapses, and then recover. There are already three drugs on the market to treat this form of the disease. Novantrone would be used for them, as well as patients with relapsing remitting multiple sclerosis that is worsening more rapidly than usual.
Patients are eager to have the new drug.
Her gait is slow, and double vision prevents her from driving. She said she received a diagnosis of relapsing remitting M.S. in 1990, and is now wondering if her condition will worsen. It's really frightening now that I'm a mother, to think that I might not be able to hold my babies. With the advisory committee's recommendation, Dr. Robert Temple, an F.D.A. official, said the agency will move quickly to make the drug available to patients. Formal approval could come within a matter of weeks, he said.