Pooled data from two large Phase III studies have demonstrated a significant early treatment effect of Novartis' multiple sclerosis pill Gilenya on relapses and MRI outcomes, including brain volume loss.
The data, presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) congress in Lyons, France, shows that treatment with Gilenya (fingolimod) led to significant benefits on relapse-related outcomes within the first three months and on brain volume loss by six months compared to placebo. Specifically, in the FREEDOMS study, treatment with the once-daily pill resulted in, on average, a 35% reduction in brain volume loss compared with placebo after six months of treatment. In FREEDOMS II, there was a 39% reduction.
David Epstein, head of Novartis Pharma, said that "as the first once-daily oral MS therapy, growing real-world experience reinforces Gilenya's high efficacy and long-term safety profile". The company also quoted Ludwig Kappos, chair of neurology at University Hospital, Basel, Switzerland, as saying that "understanding the onset of efficacy is an important consideration in the treatment of MS as early effective treatment may improve patient outcomes".
Other Novartis data presented at ECTRIMS includes first results from 1850 patients enrolled in the PANGAEA observational study in Germany. This shows that 90% of investigators and 91% of patients rated Gilenya treatment success, defined as efficacy and tolerability, as 'good' or 'very good'.
In addition, a separate analysis of time to discontinuation of therapy among MS patients receiving Gilenya and other disease modifying treatments (DMTs) using pharmacy claims in the US (n=1891) show Gilenya-treated patients were significantly less likely to discontinue treatment over the 12 month observation period (Gilenya: 27.8%, other DMT cohorts: 42.7-54.5%) and discontinued later than patients using injectable DMTs.