Novartis gets FDA approval for Mayzent (Siponimod), the first oral drug to treat SPMS

Novartis gets FDA approval for Mayzent (Siponimod), the first oral drug to treat SPMS

INforMS, Partners

EAST HANOVER, N.J., March 27, 2019 /PRNewswire/ –Novartis today announced that the US Food and Drug Administration (FDA) has approved Mayzent® (siponimod) for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome (CIS, is defined as a first episode of neurologic symptoms that lasts at least 24 hours and is caused by inflammation or demyelination in the central nervous system (CNS)3), relapsing remitting disease, and active secondary progressive disease, in adults. SPMS is a debilitating form of multiple sclerosis (MS) characterized by progressive and irreversible neurological disability4. Mayzent is expected to be available in the US in approximately one week.* Patients will not require a first dose observation (FDO, cardiac monitoring upon initiation) unless they have certain pre-existing cardiac conditions…[more]

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Elizabeth Porco

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Imagerywork

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AIMS presents the latest on multiple sclerosis treatments

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Biogen Idec’s PLEGRIDY approved in the US for the treatment of multiple sclerosis

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PLEGRIDY (Peginterferon beta-1a) approved in the EU for the treatment of multiple sclerosis

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Teva files citizen petition with the US FDA regarding the complexity of COPAXONE

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Genzyme’s Lemtrada approved in Argentina for treatment of multiple sclerosis

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Biogen Idec and AbbVie Announce Results from Phase 3 Study Investigating Daclizumab

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Genzyme’s Lemtrada resubmission accepted for review by FDA

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Data from Biogen Idec’s portfolio of multiple sclerosis therapies and pipeline featured at congresses

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Biogen Idec announces official partnership with Sailing Sclerosis’ “Oceans of Hope”

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EMD Serono data at CMSC & ACTRIMS Annual Meeting reinforces proven efficacy of rebif

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Acorda Therapeutics to showcase online multiple sclerosis resources at 2014 CMSC/ACTRIMS meeting

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Genzyme recognizes sixth annual World MS Day

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CHMP adopts positive opinion for PLEGRIDY as a treatment for multiple sclerosis in the EU

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Opexa reaches enrollment target in phase IIb trial of personalizedimmunotherapy for SPMS

Teva announces COPAXONE recognized as “Brand of the Year” by Pharm Exec Magazine

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New TYSABRI analysis shows improved walking speed in significant number of multiple sclerosis patients

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New data reinforce efficacy of TECFIDERA in multiple sclerosis patients with high disease activity

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A farewell tribute to Mike Robinson – President, National Multiple Sclerosis Society of Zimbabwe

Slowing of brain atrophy sustained at three years in patients treated with Lemtrada

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Genzyme announces multi-year multiple sclerosis research collaboration with academic medical center

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Dr. T.J. ‘Jock’ Murray is a 2014 inductee to the Canadian Medical Hall of Fame

Teva announces supreme court denial of request for interim relief to stay

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Biogen Idec to present new clinical data at AAN Annual Meeting

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New continuing education program helps distinguish between primary care needs & multiple sclerosis symptoms

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