Most think Tysabri should be restored

Most think Tysabri should be restored

An Instant Poll on Drug Topics' Web site, posted in February, found that most respondents think that Tysabri (natalizumab, Biogen Idec) should be brought back to the market. Out of 145 people who voted, 68% said the multiple sclerosis agent should be brought back but with new warnings added, 16% said it should be restored with no new restrictions added, only 10% said it should not be returned to market, and 6% said they didn't know whether FDA should let it come back. The agency suspended its marketing in February 2005 following two confirmed cases (one fatal) of progressive multifocal leukoencephalopathy (PML), a resulting neurological disorder following infection of the central nervous system by a virus. A second fatality due to PML was confirmed shortly after the drug was withdrawn from the market. Since then, the FDA has reviewed detailed information from the company regarding the condition of all patients who had received the drug in clinical studies; no additional cases of PML were identified. The FDA has now decided that natalizumab may now resume clinical trials in patients with relapsing-remitting disease who had previously been treated with the drug. The agency recommends physicians and their patients discuss the potential risks and benefits of resuming treatment with the study physician and fully understand the requirements of the new monitoring programs.

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