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news.Biogen Idec and Elan Corporation have reported that no new confirmed cases of progressive multifocal leukoencephalopathy have been found in multiple sclerosis patients treated with Tysabri in an ongoing safety evaluation of the suspended drug.
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Three confirmed cases of multifocal leukoencephalopathy (PML), a rare demyelinating disease of the central nervous system, had previously been reported in patients treated with Tysabri (natalizumab), which Biogen and Elan removed from the US market in February this year. Two of the cases of PML were fatal.
However, following the positive safety trial news, the companies have revealed plans to make submissions to regulatory authorities in early fall in the hope of taking a step towards gaining permission to restart clinical trials in MS.
More than 2,000 MS patients from clinical trials were eligible for the safety evaluation. To date, 91% of these patients participated in the program. The safety evaluation also included the review of any reports of potential PML in patients receiving Tysabri in the commercial setting.
“The findings…are an important milestone in understanding the appropriate benefit-risk profile for Tysabri. Patient safety remains our top priority. We look forward to working with regulatory authorities to determine the path forward for Tysabri,” said Dr Lars Ekman, executive vice president and president of R&D at Elan.
The positive developments have boosted shares in both companies. Irish drug maker Elan’s share value increased by 16% in the US following the news, while Biogen’s were up by 6%.