An experimental drug for multiple sclerosis (MS) that was approved in 2004, then abruptly yanked off shelves last year because of safety concerns, may get a second chance.
Two studies show that the drug can curb MS symptoms and slow progression of the autoimmune disease over 2 years, the longest tests of this drug to date. A third investigation finds no further cases of the often-fatal complication that sidetracked the drug last year, beyond the three patients who fell ill at that time. All three papers appear in the March 2 New England Journal of Medicine.
The drug, natalizumab, was pulled 4 months after its approval by the Food and Drug Administration. Three patients in clinical trials had developed progressive multifocal leukoencephalopathy (PML), a rare nervous system disorder caused by a virus that attacks people with suppressed immunity. The withdrawal came after doctors had written roughly 7,000 prescriptions for natalizumab for MS, rheumatoid arthritis,