Novartis to present new Gilenya analyses at the 67th American Academy of Neurology (AAN) Annual Meeting in Washington, DC, USA from April 18-25, 2015, showing how Novartis is advancing methods assessing the impact of relapsing multiple sclerosis (RMS) for patients and physicians. Data will show how adding brain shrinkage (brain volume loss) to an existing tool to assess MS disease activity (m-Rio) will give a more precise prediction of the likelihood of future disability progression. Accurate assessment of disease activity is key to guide treatment decisions in RMS.
A pooled analysis from the two-year phase III FREEDOMS and FREEDOMS II trials will further confirm Gilenya's high efficacy in previously-treated patients with highly-active RMS in achieving 'no evidence of disease activity' (NEDA4) across four key measures: relapses, MRI lesions, brain shrinkage and disability progression. Achieving NEDA4 is especially critical for highly-active RMS patients, who are likely to lose more physical and cognitive functions over time despite being treated.
"Novartis is committed to innovation beyond the research and development of new treatments, to help physicians and patients improve how multiple sclerosis is managed," said Vasant Narasimhan, Global Head of Development at Novartis Pharmaceuticals. "These Gilenya data and new methods of assessing the impact of MS have the potential to give physicians a more comprehensive picture of an individual's disease and allow patients to better understand their MS."
Additional data will also be presented on ASSESS-MS, a project in early development which uses an innovative movement recording system and aims to quantify an individual's level of disability in a non-invasive, patient-friendly manner. It measures a patient's movements using the Microsoft Kinect sensor with machine learning algorithms. Developed in collaboration with leading MS experts and Microsoft Research, ASSESS-MS may have the potential to change how neurological dysfunction and disability progression are assessed in MS patients.
Novartis MS portfolio highlights at AAN will include three poster presentations on ASSESS-MS; 16 presentations on Gilenya trial analyses; and one poster presentation on BAF312, an S1P-modulator that is being investigated for secondary progressive MS (SPMS).
Multiple sclerosis (MS) is a chronic disorder of the central nervous system (CNS) that disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss. The evolution of MS results in an increasing loss of both physical and cognitive (e.g. memory) function. This has a substantial negative impact on the approximately 2.3 million people worldwide affected by MS, a disease that most often begins in early adulthood.
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. Gilenya is approved in the US for the first-line treatment of relapsing forms of MS in adults. In the EU, Gilenya is indicated 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 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 relapsing MS to effectively impact disease activity and help preserve an individual's functions.
The safety profile of Gilenya in RMS is well understood and based on substantial evidence from three major clinical trials and extensive real-world experience in more than 114,000 patients, with the total patient exposure now at approximately 195,000 patient years.
Novartis is committed to the research and development of new treatment options to offer the right treatment to the right patient at the right time, to meet patients' needs at every stage of disease with innovative and targeted drugs.