FDA approves Novartis Mayzent (siponimod) for treatment of adult patients with recurrent multiple sclerosis
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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recently, Novartis(http://announced that the U.SFDA(http://approved its development of Mayzent (http:// for the treatment of recurrent multiple sclerosis (RMS) adult patients, including active secondary progressive disease (active SPMS), recurrent recurrent disease (RRMS) and clinical isolation syndrome (CIS)MayzentNovartis developed Mayzent as a highly selective regulator for specific subtypes of S1P receptorsIt can selectively bind to S1P1 and S1P5 receptor subtypesWhen combined with the S1P1 receptor subtype expressed on the surface of lymphocytes, it prevents lymphocytes from entering the central nervous system (CNS) in MS patients, thereby reducing the inflammatory responsePreclinical studies have shown that thisdrug(http://prevent neurodegenerative lesions from synapsesIt has the potential to change the course of diseaseTHE EXPAND STUDY
THIS APPROVAL IS BASED ON MAYZENT'S PERFORMANCE IN A RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 CLINICAL
TRIAL
(HTTP://WWW.CHEMDRUG.COM/SELL/24/)
CALLED EXPAND the patient group who participated in these trials was a typical SPMS patient who had been suffering from MS for nearly 16 years, and more than 50 percent of patients had an average median extended disability status scale (EDSS) score of 6 and needed to walk with a walker compared to placebo, Mayzent significantly reduced the risk of confirmed disability progression (CDP) after 3 months and a 21% lower risk compared to placebos (p-0.013) Also, Mayzent significantly delayed the risk of CDP by 6 months, with a 26% lower risk compared to placebos (p-0.0058) At the same time, Mayzent reduced the annual recurrence rate by 55%
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