- The EXPAND study shows new treatment, siponimod, is the first potential therapy to meaningfully delay disability in people with secondary progressive MS
- Results demonstrate siponimod also had beneficial effects on relapses and disease activity, including brain volume loss (brain shrinkage)
Pharmaceutical company Novartis today announced that the full results from the EXPAND study of siponimod (BAF312) in secondary progressive multiple sclerosis (SPMS) were published in medical journal The Lancet. These pivotal results show significant reductions in the risk of three and six-month disability progression with siponimod versus placebo and favourable outcomes in other relevant measures of MS disease activity. If approved, siponimod would be the first disease-modifying therapy to delay disability progression in typical patients with secondary progressive MS, including many who had reached a non-relapsing stage and high level of disability. Novartis plans to file for a European license in 2018.
“Currently, Irish people with secondary progressive MS have limited treatment options. This new data, published today, shows that siponimod delays the advancement of disability for these patients, representing an important milestone in MS care”, says Professor Orla Hardiman, Consultant Neurologist, Beaumont Hospital and Professor of Neurology, Trinity College, Dublin. “These data are all the more impressive when considering that the majority of patients already had advanced disability when starting treatment on the study”.
Siponimod is an oral selective modulator of sphingosine-1-phosphate (S1P) receptor subtypes one and five (S1P1 and S1P5). Full data from EXPAND show that siponimod reduced the risk of three-month confirmed disability progression by a statistically significant 21% versus placebo, efficacy was consistent across many sub groups. Other clinically relevant endpoint data show that siponimod, when compared to placebo:
- Reduced the risk of six-month confirmed disability progression by 26%
- Slowed the rate of brain volume loss (brain shrinkage) by 23%
- Limited the increase of brain lesion volume by approximately 80%
- Reduced annualised relapse rate by 55%
- Did not show a significant difference in the Timed 25-Foot Walk test and MS Walking Scale
- Demonstrated a safety profile that was overall consistent with the known effects of S1P receptor modulation
“Novartis is dedicated to advancing MS research and pioneering solutions for people living with secondary progressive MS – a complex, debilitating disease,” said Danny Bar-Zohar,
Global Head, Neuroscience Development for Novartis. “The pivotal EXPAND data provides patients, and the medical community alike, with hope that a much needed, safe and effective treatment option is on the horizon for secondary progressive MS, for which treatment options are scarce. We look forward to continuing to work with regulatory agencies to make siponimod available for these patients as fast as possible.”
Novartis has initiated a scientific advice consultation with the European Medicines Agency (EMA) and, pending its outcome, plans to file for a license in Q3 2018. If siponimod is granted a license by the EMA, the company will then need to apply to the National Centre for Pharmaco-economics (NCPE) and the HSE to see if the drug will be approved for reimbursement in Ireland. Read more about the process by which new medications are made available in Ireland
MS Ireland, along with other patient organisations, have strong concerns about current problems and delays in the system for making new and innovative medications like siponimod available in Ireland. MS Ireland have contributed to two round-table discussions and subsequent reports produced by the Irish Platform for Patients Organisations, Science and Industry (IPPOSI) and the Medical Research Charities Group (MRCG), which detail the problems with the system and make recommendations for change. Read the ‘Drug Iceberg’ reports.
Get in touch
Please contact Harriet Doig, Information, Advocacy and Research Officer, for further information on MS Ireland’s work on access to medicines – harrietd@ms-society.ie