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If approved, Mayzent will be the first and only oral disease-modifying therapy for this patient population.
The CHMP positive opinion for Mayzent is based on data from the Phase III EXPAND study, a randomised, double-blind, placebo-controlled trial comparing the efficacy and safety of Mayzent versus placebo in 1651 people with SPMS with varying levels of disability (Expanded Disability Status Scale [EDSS] scores of 3.0 to 6.5). Mayzent was shown to reduce the risk of disability progression with a safety profile that was overall consistent with the known effects of S1P receptor modulation. Specifically, in the post hoc analysis of the active SPMS subgroup (n=779), results demonstrated that Mayzent reduced the risk of three- and six-month confirmed disability progression by 31% (p=0.0094) and 37% (p=0.0040) respectively versus placebo.
Additionally, a sub-group analysis of the EXPAND study showed that Mayzent had functional benefits on cognitive processing speed, the cognitive function most frequently affected by MS. Further analyses have shown that Mayzent may help patients preserve their mobility for over four years longer on average, and that it reduced loss of cortical grey matter and thalamic volume – key drivers of disability progression and declining cognitive function in patients with SPMS.
“Until recently, although we have made considerable strides in reducing relapses and long term disability in patients with relapsing remitting disease, there was little to offer patients who had reached the secondary progressive stage of the disease. Results from the EXPAND study demonstrate that Mayzent has a positive impact on reducing both cognitive and physical decline, offering renewed hope for people living with active SPMS,” said Dr Eli Silber, Consultant Neurologist at King’s College Hospital NHS Foundation Trust. “The CHMP’s positive recommendation heralds a new era of care for people with active SPMS, potentially offering the multiple sclerosis community, for the first time, a much-needed treatment that is proven to delay disability progression.”
“At Novartis, we are committed to reimagining care for patients across the MS spectrum, and today’s positive decision marks a significant step towards building a better future for people living with active SPMS,” said Haseeb Ahmad, Managing Director UK, Ireland and Nordics, Novartis Pharmaceuticals & Country President UK. “Mayzent offers the potential to expand possibilities for those living with the condition by delaying the progression of disability. We will continue working closely with regulatory bodies to make sure this new treatment is made available in the UK for those who it could benefit.”