Positive results in three studies of Gilenya (Novartis) for patients with Multiple Sclerosis - 13-Oct-2012

Three new studies of Gilenya (fingolimod), from Novartis, reinforce the generally early and sustained efficacy benefit and long-term safety profile that the drug demonstrates in patients with Multiple Sclerosis. A new post hoc analysis of two Phase III studies (FREEDOMS and FREEDOMS II) showed that patients receiving the drug saw significant benefits on brain volume loss and relapse-related outcomes compared to placebo within the first six months. In addition, a new integrated analysis of safety data from Phase II, Phase III and study extensions for fingolimod (all doses, n=3553) show a safety profile generally consistent with previous results. The total fingolimod exposure was 9,070 patient years, with 1,510 patients treated for more than three years and some for more than seven years.

Finally, initial results from the PANGAEA observational study in Germany indicate that 90% of investigators and 91% of patients rated fingolimod treatment success, defined as efficacy and tolerability, as “Good” or “Very Good”. PANGAEA is a German registry study aimed to enroll a total of 4,000 patients with a follow-up of five years designed to investigate the efficacy and safety of fingolimod in everyday clinical practice. As of May 2012, one year after initiation of the registry, more than 1,850 patients were enrolled in 475 participating centres. These results also showed an overall safety profile in line with previously reported data.

All the new data was presented at the 28th congress of the European Committee for Treatment and Research in Multiple Sclerosis.