Novartis reports positive data from recent Mayzent study

Novartis announced a new analysis of the phase 3 ‘EXPAND’ study on Wednesday, demonstrating that treatment with ‘Mayzent’ (siponimod) had a clinically meaningful positive impact on cognitive processing speed (CPS) in patients with secondary progressive MS (SPMS), which it said was an important element in cognitive function.

The Swiss pharmaceuticals firm said the EXPAND data also showed that patients treated earlier in the course of their disease with less cognitive impairment benefited most from Mayzent treatment compared to placebo, suggesting early treatment was important to ensure better cognitive outcomes, which it said was critical in helping patients maintain their independence for longer.

It explained that the findings were being presented at the 2019 American Academy of Neurology annual meeting in Philadelphia.

Mayzent is the only FDA-approved treatment for active SPMS, based on a positive pivotal study of a typical SPMS patient population.

Novartis said impairment in cognitive function substantially impacted the lives of patients with MS and their families.

Between half and three-quarters of people with MS were unemployed within 10 years of diagnosis, with cognitive impairment being the leading predictor of occupational disability.

Furthermore, patients who experience impaired cognitive function participated in social activities less frequently, Novartis said, which could have an impact on their overall wellbeing and relationships.

“Cognitive decline is a real fear among people with multiple sclerosis, a fear that can be even bigger in patients with SPMS,” said Ralph Benedict, professor of neuropsychology at Buffalo General Medical Center and an EXPAND study investigator.

“The EXPAND study revealed exciting findings for SPMS patients and the scientific community.

“We are delighted to see Mayzent may protect against cognitive decline, as preserving cognitive function is a crucial aim of disease-modifying MS treatments.”

In EXPAND, Mayzent's effect on CPS was measured by a standard test.

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, the company said in its statement.

Its worsening was often the first noticeable sign of a decline in cognitive function in MS, and it significantly affected quality of life, as simple tasks became more and more difficult.

The data presented showed that a significantly higher proportion of patients treated with Mayzent experienced sustained improvement in SDMT compared to those on placebo placebo.

"The significant effects on cognitive impairment presented at AAN continue to build on the evidence that Mayzent can delay disability progression and positively impact patients' lives,” said Danny Bar-Zohar, global head of neuroscience development at Novartis Pharmaceuticals.

“With Mayzent, we finally have a therapy with proven efficacy in SPMS.”

In March, Novartis received approval from the FDA for Mayzent across the MS spectrum for clinically isolated syndrome CIS, RRMS, and active SPMS.

Patients starting Mayzent treatment did not require a first dose observation unless they had certain pre-existing cardiac conditions.

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