Tysabri makers report no new PML cases in drug evaluationBiogen Idec and Elan announced that findings from their safety evaluation of the suspended drug Tysabri (natalizumab) in patients with Crohn's disease and rheumatoid arthritis, resulted in no new confirmed cases of the rare brain disease progressive multifocal leukoencephalopathy (PML).
Both companies reported similarly positive results in August in a screening of nearly 2,000 sufferers of multiple sclerosis, who took the drug in clinical trials.
In their statement, Biogen and Elan said the safety evaluation into PML risks among patients in clinical trials is now complete.
Biogen and Elan voluntarily suspended Tysabri from the U.S. market in February after three confirmed cases of PML, two of which were fatal, were reported in patients taking the drug.
In a Wall Street Journal report, analysts said they expected a restricted return of Tysabri to the market in several months rather than in years.