NOVARTIS AG While MS progression is different for each patient and influenced by multiple factors, including use of MS disease-modifying treatments, it is estimated that up to 80% of patients will eventually transition from RRMS to SPMS [3]. If approved, Mayzent is expected to be the first and only oral treatment specifically indicated for patients with active SPMS based on a randomized clinical trial of a broad SPMS patient population.
'Today's CHMP opinion marks a milestone in supporting people in
The positive CHMP opinion for Mayzent is based on groundbreaking data from the Phase III EXPAND study, a randomized, double-blind, placebo-controlled trial, comparing the efficacy and safety of Mayzent versus placebo in people with SPMS. EXPAND also investigated a subgroup of patients with active disease (n=779), defined as patients with relapses in the two years prior to the study and/or presence of Gd-enhancing T1 lesions at baseline. The baseline characteristics were similar except for signs of activity compared to the overall population. Results from EXPAND in the overall population showed that Mayzent significantly reduced the risk of three-month confirmed disability progression (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].
About Mayzent (siponimod)
Mayzent is a next generation, selective sphingosine 1-phosphate receptor modulator approved by the FDA for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome (CIS(+)), relapsing remitting disease, and active secondary progressive disease, in adults. Mayzent 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 CNS of patients with MS [2]. This leads to the anti-inflammatory effects of Mayzent [8]. Mayzent also enters the CNS [9,10,11] 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 MS [12,13,14].
About the EXPAND Study [2]
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, however, 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).
About Multiple Sclerosis
MS disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss [15]. MS, which affects approximately 2.3 million people worldwide [3], is often characterized into three forms: primary progressive MS (PPMS) [16], 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 disability [17]. Approximately 85% of patients initially present with relapsing forms of MS [3]. 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) [17].
About Novartis in MS
The Novartis multiple sclerosis portfolio includes Gilenya (fingolimod, an S1P modulator), which is indicated in the
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 108,000 people of more than 140 nationalities work at Novartis around the world.
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