Novartis:Long-term efficacy of Gilenya

Novartis has announced a new analysis from the phase III FREEDOMS and FREEDOMS II trials reinforcing the long-term efficacy profile of Gilenya (fingolimod). The analysis evaluated the proportion of Gilenya patients with relapsing multiple sclerosis (RMS) achieving ‘no evidence of disease activity’ (NEDA-4) every year over seven years.

Novartis explains that NEDA-4 is achieved when a patient has no relapses, MRI lesions, MS-related brain shrinkage and disability progression. These data were presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain.

This follow-up analysis of pooled data from the FREEDOMS and FREEDOMS II core and extension trials was conducted to assess NEDA-4 each year for seven years in patients with RMS. The data showed that in the first year, 27.1% of patients on Gilenya achieved NEDA-4 compared to 9.1% on placebo. Switching from placebo to Gilenya after year two doubled the proportion of patients achieving NEDA-4 (12.7% to 27.4%) in year three. Of those patients on continuous Gilenya treatment, 31.2% to 44.8% had NEDA-4-status in each of the years three to seven[1].

“MS is a chronic debilitating disease and these data are important in showing the long-term efficacy of Gilenya, and the importance of early treatment to help improve long-term outcomes for patients,” said Vas Narasimhan, Novartis Global Head of Development.

“Better understanding of the course of a person’s MS through assessment of NEDA-4 can help physicians identify the optimal, effective treatment approach as early as possible for their patients.”

A separate follow-up analysis of data from the FREEDOMS and FREEDOMS II trials also confirmed for the first time that assessment of RMS based on NEDA-4 allowed physicians to better predict long-term disability and brain shrinkage outcomes than just assessing relapses, MRI lesions and disability progression. NEDA-4 status over the first year was a significantly better predictor of disability and brain shrinkage over the subsequent five years, as measured by patients reaching a stage of severe disability (EDSS >=6: patients require a crutch to walk approximately 100m) (p<0.0127) or having more than 0.4% mean annual brain volume loss[2]. These findings support the importance of assessing RMS with NEDA-4 to enable a more reliable prediction of long-term disease outcomes, said the company.

Novartis About Gilenya

Gilenya is the only oral disease-modifying therapy (DMT) to impact the course of relapsing MS (RMS) with high efficacy across four key measures of disease activity: relapses, MRI lesions, brain shrinkage (brain volume loss) and disability progression. It is approved in the US for the first-line treatment of relapsing forms of MS in adults and in the EU for adult patients with highly-active relapsing remitting MS (RRMS) defined as either high disease activity despite treatment with at least one DMT, or rapidly-evolving severe RRMS.

Gilenya targets both focal and diffuse central nervous system (CNS) damage. It prevents cells that cause focal inflammation from reaching the brain (referred to as ‘peripheral’ action), but also enters the CNS and reduces the diffuse damage by preventing the activation of harmful cells residing in the CNS (referred to as ‘central action’). It is important to address both focal and diffuse damage in RMS to effectively impact disease activity and help preserve an individual’s functions.

 Gilenya has been used to treat approximately 125,000 patients in both clinical trials and the post-marketing setting, with more than 240,000 years of patient experience. The overall benefit risk profile of Gilenya remains positive.