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Biogen Idec, Elan say FDA accepts Tysabri application for priority review to treat multiple sclerosis
New York, Nov. 17 - Biogen Idec and Elan Corp. plc said their supplemental Biologics License Application for Tysabri (natalizumab) to treat multiple sclerosis has been accepted for priority review by the Food and Drug Administration.
Given the priority status, the companies expect action six months from submission rather than the standard 10 months.
The FDA grants priority review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need, the two companies noted.
Included in the application is final two-year data from the phase 3 Affirm monotherapy trial and Sentinel add-on trial with Avonex (Interferon beta-1a) in multiple sclerosis, integrated safety assessment of patients treated with Tysabri in clinical trials; and a revised label and risk management plan.
"We are pleased that Tysabri has received priority review designation, which we believe, reflects the unmet need in MS," said Burt Adelman, executive vice president, development at Biogen Idec, in a news release.
Biogen and Elan voluntarily suspended Tysabri from the U.S. market and halted all ongoing clinical trials on Feb. 28 in response to reports of progressive multifocal leukoencephalopathy, a rare and potentially fatal demyelinating disease of the central nervous system.
Biogen Idec and Elan recently completed a comprehensive safety evaluation of more than 3,000 Tysabri patients in collaboration with leading experts in progressive multifocal leukoencephalopathy and neurology.
The results of the safety evaluation yielded no new confirmed cases of progressive multifocal leukoencephalopathy beyond the three previously reported, the companies said.
Biogen is a Cambridge, Mass., biotechnology company. Elan is a Dublin, Ireland, biotechnology company.
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