TYSABRI SUBMISSION INCLUDES LABEL REVISIONS, RISK MANAGEMENT PLAN
Biogen Idec and Elan's plan to revive its withdrawn multiple sclerosis (MS) drug Tysabri includes revisions to the product's label, as well as the establishment of a risk management plan for the drug.
The firms recently announced they had filed a supplemental biologics license application (sBLA) with the FDA, seeking permission to return the drug to the market as a treatment for MS. The filing comes roughly seven months after Biogen and Elan voluntarily suspended marketing and clinical use of Tysabri (natalizumab), following reports that three patients taking the drug in a clinical trial contracted progressive multifocal leukoencephalopathy (PML), a rare and frequently fatal demyelinating disease of the central nervous system.
Although the companies are still negotiating the label changes with the FDA, they indicated that a black box warning for PML would be included in the new label. However, the companies are not expected to remove existing label information regarding Tysabri's use in combination with Biogen's older MS treatment Avonex (interferon beta-1a) -- a move that caught some observers by surprise.
In addition to the label changes, Biogen and Elan's sBLA calls for the creation of a risk management plan that would include a patient registry. The application also includes final two-year data from the Phase III AFFIRM monotherapy trial and SENTINEL add-on trial with Avonex study, as well as an integrated safety assessment of patients treated with Tysabri in clinical trials.
Biogen and Elan are seeking priority review for the sBLA, which, if granted, would put the application on target for a user fee date in late March 2006. The companies said they plan to submit a similar data package to the European Medicines Agency, which has yet to approve Tysabri.
Tysabri was projected to reach blockbuster status when it was approved by the FDA last November, but the PML setback is expected to hinder its future performance.