Prescribing information

 

Overview of the EXPAND and the EXPAND extension study of MAYZENT in SPMS.

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MAYZENT was studied in EXPAND, the largest Phase III study in SPMS1

EXPAND was a randomised, double‑blind, placebo‑controlled, event and follow‑up duration driven, phase III study.1

The results from the core phase was published in The Lancet in 2018.1

The core phase (randomised, double-blind and placebo-controlled) of the study was followed by an ongoing, long-term, open-label extension phase for up to 10 years.1,2 

*Extension data cut-off: 06 April 2019 (Month 36 visit of extension); total study duration ≤5 years (core+extension). Open-label starts when patient has an “event”.2

MAYZENT was studied in a broad range of patients1

 

 Table showing the baseline characteristics of patients in the EXPAND study

 

Although the EXPAND study was in a broad SPMS population, MAYZENT is indicated for treatment of adult patients with SPMS with active disease evidenced by relapse or imaging features of inflammatory activity.1,3

Active population defined as the presence of relapses in the 2 years before screening and/or ≥1 T1 gadolinium-enhancing (Gd+) lesion at baseline.1

Indication: MAYZENT is indicated for the treatment of adult patients with SPMS with active disease evidenced by relapses or imaging features of inflammatory activity.3

ARR, annualised relapse rate; CDP, confirmed disability progression, EDSS, Expanded Disability Status Scale; EoCP, end of core part; MRI, magnetic resonance imaging; MS, multiple sclerosis; SDMT, Symbol Digit Modalities Test; SPMS, secondary progressive multiple sclerosis.

References

  1. Kappos L et al. Lancet. 2018;391(10127):1263–1273 and supplementary material.
  2. Kappos L et al. Long-term efficacy and safety of Siponimod in patients with SPMS: EXPAND extension analysis up to 5 years. Poster presented at 72nd Congress of the American Academy of Neurology; April 25–May 1, 2020;Virtual.
  3. MAYZENT Summary of Product Characteristics. January 2021.
  4. Gold R et al. Efficacy of siponimod in secondary progressive multiple sclerosis patients with active disease: the EXPAND study subgroup analysis. Poster P750 presented at: the 35th ECTRIMS Congress; 11–13 September 2019; Stockholm, Sweden.
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UK | May 2021 | 124681
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
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