Biogen Idec says that four more cases of the rare and serious neurological infection known as PML have been detected in patients taking its drug for multiple sclerosis, Tysabri.
That brings the total number of progressive multifocal leukoencephalopathy cases to 28 since July 2008.
Officials at the Cambridge, Mass.-based biotechnology company (Nasdaq: BIIB) say that even with the addition of four new cases between the end of October and the end of November, the risk of developing the infection is not higher than expected.
“The risk for patients taking the drug for less than a year is 0.4 per 1,000 and the risk for those taking it for more than two years is one in 1000, consistent with what it says on the label,” said Naomi Aoki, Biogen’s director of public affairs.
Since the risks increase the longer a patient takes the drug, the number of PML cases is expected to rise. A disproportionate share of the cases have been detected outside the U.S. Biogen officials believe a number of factors are at play in this trend, but that the relatively heavier use of other immunosuppressant treatments overseas may play a role.
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