Novartis presentation includes new data on recently FDA-approved Kesimpta

Novartis presentation includes new data on recently FDA-approved Kesimpta

September 8, 2020 Off By Dino Mustafić

Novartis will present 48 abstracts at the upcoming MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting, September 11–13, 2020. The breadth of data being presented highlights the strength and promise of the company’s MS portfolio to improve the lives of patients across the MS spectrum.

“As a global leader in neuroscience, we have been committed to bringing life-changing therapies to people living with diseases like MS for more than 75 years,” said Estelle Vester-Blokland, Global Head Neuroscience Medical Affairs, Novartis Pharmaceuticals. “For the first time in our growing portfolio, we are proud to be presenting data from three of our approved MS treatments across the MS disease spectrum, which is a significant milestone of our commitment to reimaging medicine for the MS community.”

Novartis key highlights at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting include:

New efficacy and safety data on Kesimpta, the first and only self-administered, targeted B-cell therapy for patients with relapsing MS (RMS), indicate potential benefits of starting high-efficacy therapy early with Kesimpta. Kesimpta was approved by the US Food and Drug Administration (FDA) for treatment in RMS to include clinically isolated syndrome, relapsing–remitting disease and active secondary progressive disease in adults, in August 2020.

  • New findings from the ASCLEPIOS Phase III trials demonstrate Kesimpta’s superior efficacy vs teriflunomide in newly diagnosed, treatment-naïve patients with low absolute relapse rates, very low magnetic resonance imaging (MRI) lesion activity and prolonged time to disability worsening.
  • Additional safety and efficacy data on Kesimpta show that no new safety signals were identified in patients treated with Kesimpta. In this extended analysis, Kesimpta showed a safety profile that remains consistent with data reported in the Phase II and III clinical trials.
  • Results from the ASCLEPIOS trials also demonstrated that baseline serum neurofilament light levels (sNfL) were prognostic for lesion formation and brain volume loss for at least two years. These results support that sNfL can complement clinical assessments and help identify patients at high risk for future disease activity.

New scientific evidence on Mayzent, the first and only oral treatment studied and proven to slow disability progression in a broad range of secondary progressive MS (SPMS) patients, highlight delays to disability progression and benefits in cognitive performance in patients treated with Mayzent:

  • Results from EXCHANGE interim analysis showed a good safety and tolerability profile when patients switched from an oral or injectable disease-modifying therapy (DMT) to Mayzent.
  • Further EXPAND data continue to demonstrate improvements of cognitive processing speed in patients with active and non-active SPMS treated with Mayzent.
  • Long-term data analyses from the EXPAND trial showed sustained benefits on disability, cognitive processing speed and relapse outcomes for up to five years in patients with active SPMS treated continuously with Mayzent versus those who switched from placebo, highlighting the value of early treatment initiation.

New safety data on Gilenya, a cornerstone of MS treatment and the only oral DMT approved to treat relapsing forms of MS in adults and children from 10 years of age and older, were presented:              

  • Additional safety findings from studies on Gilenya highlight a low risk of progressive multifocal leukoencephalopathy (PML) in patients receiving Gilenya, and prevalence estimates of major congenital malformations among live births are similar to those from an untreated MS population.
  • Results from the Phase IV FLUENT study, which assessed immune phenotype biomarkers in patients receiving Gilenya treatment, expand our knowledge of changes in immune cell profiles over the short and long term in RMS patients treated with Gilenya.