"....Its key recommendations for approval include:
• Tysabri be made available only to patients who have enrolled along with their physicians in a mandatory registry program;
• Tysabri be made available only to patients diagnosed with relapsing MS;
• Tysabri could be considered appropriate for use in MS patients who experience relapses regardless of their degree of disability, so that even persons with no disability or severe disability would be eligible;
• Tysabri be given only at authorized infusion centers where the medical personnel have been trained in its proper use and in the risks of PML;
• Tysabri not be used in patients who have compromised immune systems or who are taking other immunosuppressive or immunomodulatory agents, with the possible exception of periodic steroids to treat relapses;
• prescribing information carry a “black box warning” concerning PML;
• prior to starting treatment, the physician complete a “patient checklist” to ensure that the patient meets all requirements for use of Tysabri; and
• prior to each infusion, the patient and infusion nurse complete a checklist to screen for symptoms suggestive of PML.
The advisory committee did not achieve consensus on any recommendation of whether Tysabri should be used as a “first-line” therapy or whether a patient must first be on another disease-modifying therapy that proved ineffective. ...."