Second progressive multiple sclerosis (SPMS) is the first oral drug! Mayzent, a new generation of S1P receptor modulator of Novartis, is about to be approved by EU!

November 18, 2019 / BIOON / - Novartis, a Swiss pharmaceutical giant Novartis recently announced that the European Drug Administration (EMA) Committee on human medicinal products (CHMP) has issued a positive review, recommending the approval of mayzent (siponimod) for the secondary progressive multiple sclerosis of active diseases evidenced by the imaging features of recurrent or inflammatory activities (such as GD enhanced T1 lesions or active, new or expanded T2 lesions) (SPMS) treatment of adult patients Although MS progression varies 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 will eventually transition from relapsing remitting multiple sclerosis (RRMS) to SPMS The CHMP's comments will now be reviewed by the European Commission (EC), which is expected to make a final decision within the next two months If approved, mayzent will be the first and only oral drug specifically for active SPMS patients in Europe In the United States, the FDA approved mayzent in March this year for the treatment of adult patients with multiple sclerosis (MS), including active secondary progressive multiple sclerosis (SPMS), relapsing remitting multiple sclerosis (RRMS), and clinical isolated syndrome (CIS) In terms of medication, patients do not need first dose observation (FDO, cardiac monitoring at the beginning of treatment), unless there are some pre-existing heart diseases (Note: CIS is defined as the first attack of neurological symptoms, lasting at least 24 hours, caused by inflammation or demyelination of the central nervous system.) it is worth mentioning that in the United States, mayzent is the first treatment drug specifically approved for active SPMS patients in the past 15 years SPMS is a type of MS, which is characterized by progressive and irreversible neurological dysfunction Over time, up to 80% of RRMS patients will transition to SPMS Therefore, early initiation of treatment to slow disability progression is essential for patients Disability progression most often includes, but is not limited to, the impact on mobility, which may lead to the need for walking aids or wheelchairs, bladder dysfunction, and cognitive decline Mayzent can solve the critical unmet medical needs of patients with RRMS in transition period and those with active SPMS in transition Christoph thalheim, director of foreign affairs of the European multiple sclerosis platform, said: "today's CHMP comments mark a milestone in support of active SPMS patients in Europe This decision offers hope for a new and potentially beneficial treatment " The positive opinion of CHMP is based on the pioneering data of phase III expand research This is the largest randomized clinical study conducted in a wide population of SPMS patients with EDSS scores of 3.0 to 6.5 This is a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of mayozent and placebo in the treatment of SPMS patients The patients in the study represented a typical SPMS population with an average age of 48 years At the beginning of the study, these patients had MS for about 16 years More than 50% of the patients had a median extended disability scale (EDSS) score of 6.0 and relied on Walker The study also investigated a group of patients with active disease (n = 779), defined as patients with Gd enhanced T1 lesions at baseline and / or recurrence in the first two years of the study In addition to signs of activity, baseline characteristics are similar to those of the general population Results from the study population showed that mayzent significantly reduced the risk of confirmed disability progression (CDP) by 3 months (primary endpoint: 21% lower than placebo, P = 0.013), and significantly delayed the risk of CDP by 6 months (26% lower than placebo, P = 0.0058) Data in the active disease subgroup showed that: compared with the placebo group, mayzent significantly delayed the occurrence of 3-month and 6-month CDP by 31% and 37%, respectively, and reduced the annual recurrence rate (arr, confirmed recurrence) by 46% In addition, mayzent has significant favorable results in other related MS disease activity measures, including MRI disease activity and brain volume loss (brain atrophy) This year, an additional analysis of the expand study was conducted at the 35th session of the European Committee for the treatment and research of multiple sclerosis (ECTRIMS), showing that mayzent: can help patients maintain an additional average of more than four years of mobility Reduction of gray matter volume loss at 1 and 2 years is a key driver of disability progression and cognitive decline in SPMS patients John Tsai, director of global drug development and chief medical officer of Novartis, said: "it is extremely important for patients with multiple sclerosis to delay disability progression and maintain cognitive ability so that they can live longer on their own Mayzent demonstrates the mission of Novartis to redesign drugs for underserved people, such as those living in active SPM " Siponimod molecular structure formula (picture source: Wikipedia) the active drug ingredient of mayzent is siponimod, which is a new generation, selective sphingosine 1-phosphate (S1P) receptor regulator, which can selectively bind to S1P1 and S1P5 receptors When combined with S1P1 subtype receptor on lymphocytes, siponimod can prevent lymphocytes from leaving lymph nodes, thus preventing them from entering the central nervous system (CNS) of MS patients, which plays an anti-inflammatory role In addition, siponimod can also enter the CNS and directly bind to the S1P5 and S1P1 subtype receptors on specific cells (oligodendrocytes and astrocytes), which can promote the regeneration of myelin sheath and prevent inflammation In addition to the United States, mayzent was approved by the Australian treatment products authority (TGA) in November to treat adult patients with SPMS Novartis is committed to bringing mayzent to patients all over the world Currently, regulatory filings are underway in Switzerland, Japan, Canada and China Mayzent's success is crucial for Novartis, which is facing increasing competition for another $3 billion-a-year blockbuster MS oral drug, gilenya The industry is very optimistic about mayzent's business prospects Some analysts predict that the peak sales of mayzent will be as high as $3 billion after it goes public Source of the original text: Novartis receives positive CHMP opinion for mayont ® (siponimod) for the treatment of advanced patients with active secondary progressive multiple sciences (SPMS)