Biogen/Elan Seek First-Line Claim For Tysabri In JCV-Negative MS Patients
This article was originally published in Pharmaceutical Approvals Monthly
Given the risks of progressive multifocal leukoencephalopathy, a proposed restriction appears aimed at blunting the potentially unfavorable impact that longer duration of use in the first-line setting would have on natalizumab’s risk/benefit profile.
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Biogen Idec reported steady progress in the clinic for four late-stage programs, including hemophilia. Recent bumps include a three-month delay for the MS product BG-12, but nothing that would derail its Phase III pipeline.
Multiple sclerosis and Crohn’s disease patients with anti-JC virus antibodies who have previously taken other immunosuppressants have a 1.1% risk of developing the deadly neurological condition after taking Biogen Idec /Elan’s Tysabri for more than two years.
Biogen Idec expects to re-launch the multiple sclerosis therapy in July.