First secondary progressive multiple sclerosis (SPMS) oral drug! Novarma Mayzent improves cognition and slows the progression of disability and is listed in China!

September 12, 2020 // -- Novartis recently unveiled the multiple sclerosis drug Mayzent (Chinese) at the 8th ACTRIMS-ECTRIMS Joint Conference MSVirtual2020 Product Name: Wanli energy ®, generic name: siponimod, Sinimod) Treatment of secondary progressive multiple sclerosis (SPMS) IIIb phase EXCHANGE trial and Phase III EXPAND trial analysis results.
data show that Mayzent is a safe treatment that improves cognitive ability and reduces the risk of disability progress, and that the earlier treatment benefits.
Mayzent ® was approved in China to treat adult multiple sclerosis (RMS), including clinical isolation syndrome (CIS), relapsed-relieving disease (RRMS) and active secondary progressive disease (SPMS).
Over time, up to 50-60% of RRMS patients will develop into SPMS, and Mayzent ® is a next-generation, selective 1-phosphate pyrethroid (S1P) regulator, the world's first approved oral disease correction therapy (DMT) drug for SPMS, and early on on treatment can effectively slow progression and cognitive decline in disability.
EXCHANGE is a forward-looking, 6-month, open-label PHASE IIIb study that assesses the safety and tolerance of patients with relapsed multiple sclerosis (RMS) from other disease-correcting therapies (DMTs) to Mayzent therapy, including active SPMS.
-term analysis included 112 patients from 42 U.S. centers who met the safety analysis, and the data further enhanced Mayzent's safety and tolerance.
EXPAND was a randomized, double-blind, placebo-controlled Phase III study that compared the efficacy and safety of Mayzent and placebo in patients with varying degrees of disability with SPMS.
showed that early use of Mayzent slowed progress in disability and improved cognitive ability.
post-mortem ANALYSIs showed that cognitive processing speed improved in patients with active and in activity SPMS treated with Mayzent.
in patients with active diseases, increased opportunities for clinically related improvements were observed, and in patients with active SPMS who received Mayzent treatment early and ongoing, the risk of disability progression and cognitive decline was lower than in patients who delayed treatment with Mayzent.
subgroup analysis showed that in patients with active SPMS, the value of early use of Mayzent therapy was that its positive effects on disability, cognitive processing speed, and recurrence prognosticity lasted up to 5 years.
one of the biggest goals for people with multiple sclerosis is to be able to live independently for as long as possible," said Norman Putzki, global development director for neuroscience at Novartis.
released today further evidence that Mayzent can be an appropriate option for patients to safely switch treatments from other therapies through cognitive ability and the beneficial effects of delaying progress in disability.
Mayzent offers hope to patients seeking to achieve this important goal.
"Although the multiple sclerosis (MS) process is unique in each patient and is influenced by a variety of factors, including the use of MS disease modification therapy (DMT), it is estimated that up to 80% of patients with relapsed relapsed remissive multiple sclerosis (RRMS) will eventually transition to SPMS.
, it is critical for patients to start treatment early to slow the progression of disability.
disability progression most often includes, but is not limited to, effects on mobility, which can lead to patients needing walking assistance or wheelchairs, bladder dysfunction, and cognitive decline.
Mayzent's active pharmaceutical ingredient is siponimod, a next-generation, selective 1-phosphate diazine (S1P) regulator that selectively binds to S1P1 and S1P5 binds.
when combined with S1P1 subsypes on lymphocytes, siponimod prevents lymphocytes from leaving the lymph nodes, thus preventing them from entering the central nervous system (CNS) in MS patients and acting as an anti-inflammatory force.
in addition, siponimod can also enter CNS and bind directly to S1P5 and S1P1 subsumetors on specific cells (less protrusion glial cells and astrocytes) to promote myelin regeneration and prevent inflammation.
Mayzent was approved by the FDA in March 2019 for the treatment of adult patients with multiple sclerosis (RMS), including active secondary progressive multiple sclerosis (SPMS), relapsed remission-relieving multiple sclerosis (RRMS), and clinical isolation syndrome (CIS).
In the European Union, Mayzent was approved in January 2020 to treat adult patients with SPMS, specifically by the presence of active diseases evidenced by relapsed or inflammatory activity (e.g., Gd-enhanced T1 lesions or active, new or expanded T2 lesions) that delay the development of physical disability.
it's worth noting that Mayzent is the first oral drug approved for patients with SPMS for active diseases and the first to be approved for treatment for patients with SPMS for active diseases in nearly 15 years.
drug has been shown to be effective in slowing disease progression and will address a significantly unsealed medical need in the patient population of SPMS, an active disease.
is committed to bringing Mayzent to patients around the world and is currently filing regulatory filings in several countries.
Mayzent's success is crucial to Novart as the company faces increasing competition for gilenya, another $3 billion-a-year heavy MS oral drug.
industry is bullish on Mayzent's business prospects, with some analysts predicting a peak of $3 billion in sales after Mayzent's listing.
() Original origin: Novartis data show early treatment with Mayzent ® (siponimod) delays disability progression and show benefits in cognitive performance in patients with secondary multiple sclerosis (SPMS)