Although every patient's MS journey is unique, up to 80% of relapsing remitting MS (RRMS) patients will eventually transition to SPMS4. Mayzent addresses an unmet need for SPMS patients with active disease who, until now, did not have an oral treatment that has been shown to be effective in delaying progression in this patient population. The European marketing authorization makes Mayzent the first and only indicated oral treatment proven in SPMS patients with active disease based on a randomized clinical trial of a broad range of SPMS patients.
'We are delighted by the news that there is now a treatment available for people in
In the subgroup of Mayzent-treated patients with active disease, results showed: The risk of three-month and six-month confirmed disability progression (CDP) was significantly reduced by 31% compared to placebo and by 37% compared to placebo, respectively5.
Significant favorable outcomes in other relevant measures of MS disease activity, including annualized relapse rate (ARR - confirmed relapses), MRI disease activity and brain volume loss (brain shrinkage)5.
Results in the overall population showed that Mayzent significantly reduced the risk of three-month CDP (primary endpoint; 21% reduction versus placebo, p=0.013) and meaningfully delayed the risk of six-month CDP (26% versus placebo, p=0.0058)2. Mayzent also has a meaningful benefit on cognition and demonstrated clinically relevant effects on cognitive processing speed5.
'As the only indicated oral therapy proven for people living with SPMS with active disease, we are pleased that the European approval of Mayzent will help change the conversation about progressing MS and expand possibilities for patients and their caregivers,' said
Novartis is working closely with all stakeholders to ensure that eligible European patients can start benefitting from this treatment as quickly as possible. In
About Mayzent (siponimod)
Mayzent is a sphingosine 1-phosphate receptor modulator that selectively binds to S1P1 and S1P5 receptors. In relation to the S1P1 receptor, it prevents the lymphocytes from egressing the lymph nodes and as a consequence, from entering the central nervous system (CNS) of patients with MS2. This leads to the anti-inflammatory effects of Mayzent6. Mayzent also enters the CNS7,8,9 and binds to the S1P5 sub-receptor on specific cells in the CNS, including astrocytes and oligodendrocytes and has shown pro-remyelinating and neuroprotective effects in preclinical models of MS10,11,12.
In the
About the EXPAND Study2
EXPAND is a randomized, double-blind, placebo-controlled Phase III study, comparing the efficacy and safety of Mayzent versus placebo in people with SPMS with varying levels of disability, EDSS scores of 3*0-6*5. It is the largest randomized, controlled study in SPMS to date, including 1,651 people with a diagnosis of SPMS from 31 countries. Mayzent demonstrated a safety profile that was overall consistent with the known effects of S1P receptor modulation. It reduced the risk of three-month CDP by a statistically significant 21% (p=0.013; primary endpoint). CDP was defined as a 1-point increase in EDSS, if the baseline score was 3*0-5*0, or a 0*5-point increase, if the baseline score was 5*5-6*5. No significant differences were found in the Timed 25-Foot Walk Test. T2 lesion volume was reduced by 79% as compared to placebo. Additional secondary endpoints included a relative reduction in the ARR by 55%, and compared to placebo, more patients were free from Gd-enhancing lesions (89% vs 67% for placebo) and from new or enlarging T2 lesions (57% vs 37% for placebo). Additional exploratory analyses presented at the 35th
About Multiple Sclerosis
MS disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss14. MS, which affects approximately 2.3 million people worldwide4, is often characterized into three forms: primary progressive MS (PPMS)15, relapsing-remitting MS (RRMS), and SPMS, which follows from an initial RRMS course and is characterized by physical and cognitive changes over time, in presence or absence of relapses, leading to a progressive accumulation of neurological disability16. Approximately 85% of patients initially present with relapsing forms of MS4. There remains a high unmet need for safe and effective treatments to help delay disability progression in SPMS with active disease (with relapses and/or evidence of new MRI activity)16.
About Novartis in MS
In addition to Mayzent, the Novartis MS portfolio includes also Gilenya (fingolimod, an S1P modulator), which is indicated in the EU for the treatment of adult patients and children and adolescents 10 years of age and older with RRMS. In
Ofatumumab (OMB157), a fully human anti-CD20 monoclonal antibody (mAb) that targets B-cells, is in development for treating RMS. Positive Phase III data presented in
Extavia (interferon beta-1b for subcutaneous injection) is approved in the US for RMS, to include CIS, relapsing remitting disease and active secondary progressive disease. In
In the US, the
Disclaimer
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About Novartis
Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world.
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