Elan receives notification of Tysabri review

Pharmaceutical company Elan and Biogen Idec have received notification from the US Food and Drug Administration (FDA) that the Peripheral and Central Nervous System Drugs Advisory Committee will review drug Tysabri for the treatment of multiple sclerosis on March 7.

Elan and Biogen Idec were forced to withdraw the drug last February after some patients using it developed a potentially fatal brain disease, progressive multifocal leukoencephalopathy (PML). Three confirmed cases of PML were reported, two of which were fatal.

On September 26, 2005 the companies announced that they submitted to the FDA a supplemental Biologics License Application (sBLA) for Tysabri. The FDA then designated Tysabri for priority review. 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.

Based on the FDA's designation of priority review for Tysabri in MS, the companies anticipate action by the agency approximately six months from the submission date, or by late March 2006.

The sBLA includes two-year data from the Phase III Affirm monotherapy trial and Sentinel add-on trial with Avonex in MS, a revised label and risk management plan, and an integrated safety assessment of Tysabri clinical trial patients.

Biogen Idec and Elan also recently completed a comprehensive safety evaluation of more than 3,000 Tysabri patients in collaboration with leading experts in progressive multifocal leukoencephalopathy (PML) and MS. The results yielded no new confirmed cases of PML beyond the three previously reported.