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Friday, June 7, 2013 3:44 AM | Tony Miles Volg link

Gilenya benefited patients by improving all four key measures of multiple sclerosis(05/06/13)


New data will be presented at the 23rd meeting of the European Neurological Society (ENS) that show how Novartis' Gilenya (fingolimod), the first once-daily oral therapy approved to treat people with relapsing multiple sclerosis (RMS), positively impacted the key measures for multiple sclerosis (MS) - relapse rates, brain volume loss, lesions and disability progression. Improving these key measures led to favorable clinical outcomes.

New findings from the TRANSFORMS study showed that a greater proportion of patients were disease free after one year on Gilenya treatment compared to interferon. For patients on interferon during the first year, the proportion who were disease free during the second year increased after they were switched from interferon to Gilenya treatment. These findings suggest that switching from interferon to Gilenya is beneficial for patients with RMS to achieve and maintain long-term disease-free status.

In a separate analysis, patients with high disease activity who were switched to Gilenya from interferon experienced improved disease measures (annualized relapse rate and reduction in the amount of brain volume loss), regardless of previous treatment.

Further presentations at ENS will show how the targeted effect of Gilenya on the central nervous system is considered to contribute anti-inflammatory effects in MS and also support a positive benefit-risk profile for Gilenya.

"There is currently no cure for MS, and therefore it is imperative that treatments work positively to limit symptoms, disease activity and ultimately disease progression, thus reducing the burden for patients." said Dr. Timothy Wright, Global Head Development, Novartis Pharmaceuticals. "These new analyses are very encouraging in that they not only support the role of Gilenya as having an anti-inflammatory effect but also highlight how Gilenya can improve the key measures of this debilitating disease."

Additional findings from FREEDOMS and TRANSFORMS support the clinical relevance of brain volume loss in MS, reinforcing the link between loss of brain volume and disease severity including the volume of brain lesions and disability, a key measure of disease burden. Gilenya is the only approved MS treatment shown to consistently reduce brain volume loss across studies with a significant effect seen as early as six months. A low rate of brain volume loss with Gilenya was sustained for up to four years in Phase III studies and for up to seven years in patients after completing a Phase II study.