pharmatimesApril 22, 2020
Tag: Novartis , Mayzent , SPMS
New data showing the benefits of Novartis' Mayzent (siponimod) in patients with secondary progressive multiple sclerosis (SPMS) have been published in the April supplemental issue of American Academy of Neurology.
According to the Swiss drugmaker, the data "build on existing clinical evidence that Mayzent has proven to slow physical disability progression and provide cognitive benefits in people living with SPMS".
The five-year EXPAND open-label extension trial assessed the long-term efficacy and safety of the drug in patients with SPMS who, on entering the extension trial, either continued on Mayzent treatment or switched from placebo to Mayzent (placebo switch group).
Patients in the Mayzent group were significantly less likely to experience both three- and six-month confirmed disability progression compared with the placebo switch group, underscoring the advantages of early treatment initiation, the firm notes.
The new data also show a 52% reduction in the annualised relapse rate observed in the Mayzent group compared to the placebo switch group, while risk of confirmed worsening of cognitive impairment at six-months was cut by 23%. Furthermore, benefits seen in the Mayzent group were sustained for up to five years.
Additional Mayzent data shared in the same Neurology issue includes a new post-hoc analysis from EXPAND, which showed Mayzent consistently reduced cortical grey matter (by 48%-116% across all subgroups) and thalamic atrophy (by 30%-68%) in patients with SPMS, including those with less active and more advanced disease.
"Combined with other analyses, these findings could translate into a favourable impact on long-term clinical outcomes including disability progression and cognitive decline," Novartis said.
"These data highlight the critical importance of early treatment intervention with a disease-modifying treatment, such as Mayzent, to ensure the best possible long-term outcomes for patients with MS who are experiencing progression," said Bruce Cree, clinical research director and George A. Zimmermann Endowed Professor in Multiple Sclerosis, University of California, San Francisco, School of Medicine.
"It’s never too early to stay ahead of progression in multiple sclerosis, since the early identification of physical and cognitive changes – even subtle ones – can indicate MS disease progression and therefore allow for timely intervention."
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