Natalizumab

1) or • Patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesion load as compared to a previous recent MRI.

1) or • Patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesion load as compared to a previous recent MRI.

e. single disease-modifying agent) for the treatment of patients with the relapsing-remitting form of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations, to decrease the number and volume of active brain lesions identified on magnetic resonance imaging (MRI) scans and to delay the progression of physical disability.

TYSABRI is generally recommended in MS patients who have had an inadequate response to, or are unable to tolerate, other therapies for multiple sclerosis. Safety and efficacy in patients with chronic progressive multiple sclerosis, and in geriatric and pediatric patients, have not been established.

The efficacy of TYSABRI for a treatment duration beyond 2 years has not been determined. TYSABRI should be used by physicians who have sufficient knowledge of multiple sclerosis and who have familiarized themselves with the efficacy/safety profile of TYSABRI.

TYSABRI is only available through a controlled distribution program called Biogen ONETM Support Program. Under this program, only prescribers and pharmacies registered with the program are able to prescribe and dispense the product.