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Novartis: Gilenya Effective Against 4 Measures Of Disease Activity In MS

Swiss drugmaker Novartis AG (NVS) Monday said that two new analyses from the Phase III Transforms study demonstrated how its Gilenya (fingolimod) was effective against all four key measures of disease activity in multiple sclerosis - brain volume loss, lesion activity, relapse rates and disability progression.

Improvements were seen in patients who switched from standard interferon treatment to Gilenya within 12 months of the switch and up to the end of the 4.5 year extension study.

MS is a chronic neuroinflammatory and neurodegenerative illness where disease activity leads to accumulation of disability and loss of brain tissue.

The new analysis evaluated the association between measures of disease activity in the first year of therapy and long-term clinical outcomes. Gilenya increased the proportion of patients who were disease-free by almost 50 percent when switched from interferon to Gilenya in year-1 to year-2.

Patients who had disease-activity at the end of the first year were significantly less likely to remain clinically disease free during the following 3.5 years of the extension study.

A separate post-hoc analysis showed that patients who had disease-activity in the year prior to entering the study, despite prior treatment with a disease-modifying treatment, experienced sustained benefit on Gilenya with a lower annualized relapse rate compared to those who were given interferon for
the first year.

The analyses were presented at the 23rd meeting of the European Neurological Society or ENS in
Barcelona.

Dr. Timothy Wright, Global Head Development, Novartis Pharmaceuticals, said, "Data have consistently shown that treatment with Gilenya leads to more patients staying disease free, compared to standard interferon treatment."

by RTT Staff Writer

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