- March 23, 2018
- Posted by: PharmaScroll
- Category:
Multiple Sclerosis is an autoimmune disorder that occurs in Central nervous system of the body and leads to the destruction of the fatty protective substance called Myelin, which acts as an insulation for the nerve cells carrying the messages between the brain and the rest of the body. Myelin facilitates the speedy and smooth transmission of nerve messages. The damage to the Myelin layer leads to slow and less efficient delivery of messages thereby causing relapses and increasing disability in the patients.
MS has impacted the lives of around 2.5 million people across the globe and in the US alone there are more than 4 lacs cases of MS. Women are twice more likely to be suffering from Multiple sclerosis as compared to men.
SPMS is the subsequent form of RRMS and around 50% of RRMS patients progress to SPMS in a 10-year time frame. The presence of DMTs in RRMS delays the progression of disease from RRMS to SPMS in some of the patients but not necessarily would it prevent a patient to progress from RRMS to SPMS. SPMS is characterized by a continuous increase in disability and worsening of symptoms with or without the period of relapses and remissions. The patients might not have relapses at all but in SPMS the symptoms may not completely go off (plateau) in the remission period.
As per the current scenario in Multiple Sclerosis indication, there are over 15 molecules approved in the worldwide market. However, majority of the molecules are approved in the Relapsing Remitting form of Multiple Sclerosis. The more progressive forms of Multiple Sclerosis like Secondary Progressive MS are still to encounter the boom in terms of number of launched molecules and hence the indication sales.
However, Novartis today announced that the full results from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in secondary progressive multiple sclerosis (SPMS) were published in the peer-reviewed journal The Lancet. These pivotal results show significant reductions in the risk of three- (primary endpoint) and six-month confirmed 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 SPMS patients, including many who had reached a non-relapsing stage and high level of disability.
“Today’s published, full EXPAND results show that siponimod can delay disability progression in typical established SPMS patients, where other approaches tested so far have been unsuccessful,” said Professor Ludwig Kappos, University Hospital Basel and Principal Investigator of EXPAND. “These data are all the more impressive when considering that the majority of patients already had advanced disability when starting treatment in EXPAND.”
As per Novartis, 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 (p=0.013; primary endpoint); efficacy was consistent across many pre-defined 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% (p=0.0058)
- Slowed the rate of brain volume loss by 23% (relative difference; mean across 12 and 24 months, p=0.0002)
- Limited the increase of T2 lesion volume by approximately 80% (mean over 12 and 24 months, p<0.0001)
- Reduced annualized relapse rate (ARR) by 55% (p<0.0001)
- 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 SPMS – 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 SPMS, 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 plans to file for regulatory approval of siponimod for SPMS with the US Food and Drug Administration (FDA) in early 2018. Novartis has initiated a scientific advice consultation with the European Medicines Agency (EMA) and, pending its outcome, plans to file in Q3 2018. The EXPAND results have previously been presented at scientific congresses.
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News Source: https://www.novartis.com
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