Friday, 21 January 2011

Fingolimod licensed in Europe

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that:

Fingolimod is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following adult patient groups:

Patients with high disease activity despite treatment with a beta-interferon. These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of beta-interferon. Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gadolinium-enhancing lesion. A “non-responder” could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year.

OR

Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

Click here for summary report

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