Mayzent's data shows a positive impact on cognitive processing speed in people living with secondary progressive MS

Novartis announced a new analysis of the Phase III EXPAND study demonstrating that treatment with Mayzent (siponimod) had a clinically meaningful positive impact on cognitive processing speed (CPS) in patients with SPMS, an important element in cognitive function. The EXPAND data also show patients treated earlier in the course of their disease with less cognitive impairment - benefited most from Mayzent treatment vs. placebo, suggesting early treatment is important to ensure better cognitive outcomes which is critical in helping patients maintain their independence for longer. These findings are being presented at the 2019 American Academy of Neurology Annual Meeting (AAN) in Philadelphia, Pennsylvania, USA. Mayzent is the only FDA-approved treatment for active SPMS based on a positive pivotal study of a typical SPMS patient population.

Impairment in cognitive function substantially impacts the lives of patients with MS and their families. Half to three-quarters of people with MS are unemployed within 10 years of diagnosis, with cognitive impairment being the leading predictor of occupational disability. Furthermore, patients who experience impaired cognitive function participate in social activities less frequently which may have an impact on their overall wellbeing and relationships.

In EXPAND, Mayzent's effect on CPS was measured by a standard test (Symbol Digit Modalities Test, SDMT). CPS affects everyday activities of patients such as remembering information learned in the past or recalling information to complete a task, finding words and holding conversations, processing information and responding as quickly as they once did. Its worsening is often the first noticeable sign of a decline in cognitive function in MS and it significantly affects patients' quality of life, as simple tasks become more and more difficult.

The data presented at AAN show that a significantly higher proportion of patients treated with Mayzent experienced sustained improvement in SDMT versus those on placebo placebo ( p = 0.0131 ). Mayzent was superior to placebo across the entire spectrum of SPMS, and specifically: • Patients treated earlier in their disease course with less cognitive impairment - benefited most from Mayzent treatment, with a significantly higher proportion experiencing meaningful improvement over the course of the study and follow up ( p = 0.0126 for those with relapses and p = 0.0094 for those with an initial SDMT score >= median).• There was also a benefit from Mayzent treatment in delaying deterioration in SDMT ( p = 0.0269 for those with cognitive impairment at baseline and p = 0.0071 for those with an initial SDMT score < median) for those with more advanced disease. However, treatment with Mayzent did not result in significant differences in tests such as the Brief Visuospatial Memory Test-Revised (BVMT-R, assessing memory). Data previously published from EXPAND show Mayzent significantly slowed the rate of brain shrinkage in patients with SPMS by more than 20% (relative difference; mean across 12 and 24 months, p = 0.0002 ). Brain shrinkage was found to be related to loss of cognitive function and disability progression.

Comment: Regulatory action for Mayzent in the European Union is anticipated in late 2019, with additional regulatory action anticipated in Switzerland, Japan, Australia and Canada this year.