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"After being voluntarily withdrawn from the market in February 2005 with reports of three serious adverse events in patients involved in clinical trials, Biogen Idec and Elan Corporation's multiple sclerosis treatment Tysabri (natalizumab), is poised to return to the market- albeit with restrictions- following approval by a US Food and Drug Administration (FDA) advisory committee.
More time required
Originally the FDA was expected to make its official decision at the end of March. However, both Biogen Idec and Elan have been informed by the FDA that it is extending its regulatory review of Tysabri as a treatment for multiple sclerosis (MS) by up to 90 days. The FDA says it requires additional time to review information regarding the Tysabri risk management plan, says Life Science Analytics Inc (LSA) CEO Dr Robert Naismith. "Under this revised timeline, the companies anticipate action from FDA on or before June 28, 2006. However Biogen Idec and Elan are still expecting FDA action in late March with regard to Avonex with Tysabri therapy."
Tysabri (natalizumab) is a monoclonal antibody for the treatment of multiple sclerosis. According to LSA's online biotech research tool MedTRACK, Biogen Idec reported revenues from Tysabri sales of $US3 million for Q4 2004, while Elan reported sales of $US6.4 million for the same period. However, after two fatal, confirmed cases and one suspected case of progressive multifocal leukoencephalopathy (PML), a rare and frequently fatal demyelinating disease of the central nervous system in two patients that had been receiving Tysabri therapy, it was withdrawn from the market. Both patients had received treatment with Tysabri in combination with Avonex in clinical trials.
Avonex is another Biogen Idec drug for treating MS."
