Novartis Announces FDA And EMA Filing Acceptance Of Siponimod

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(RTTNews.com) - Novartis ( NVS ) said that both the US Food and Drug Administration and European Medicines Agency have accepted the company's New Drug Application and Marketing Authorization Application respectively, for investigational oral, once-daily siponimod or BAF312 for the treatment of secondary progressive multiple sclerosis or SPMS in adults.

The phase of multiple sclerosis or MS can substantially impact lives, due to physical and cognitive impairments. To bring this treatment to the MS community as quickly as possible, Novartis used a review voucher to expedite the review of siponimod in the US. Regulatory action for siponimod is anticipated in the US in March of 2019 and in Europe in late 2019.

More than 80% of people with relapsing-remitting MS (RRMS) - the most common form of the condition at diagnosis - go on to develop SPMS, with or without relapses. SPMS is a form of MS that leads to progressive, irreversible disability, such as the need for enhanced walking aids and wheelchairs, bladder dysfunction and cognitive decline, largely independent of relapses. Following the initial RRMS course, there is a gradual increase in the number of patients transitioning to SPMS, with around 25% progressing by 10 years post-onset, 50% by 20 years and more than 75% by 30 years.

In Switzerland, Swissmedic granted fast track authorization procedure for siponimod in SPMS. Discussions with additional health authorities regarding siponimod are ongoing.

Read the original article on RTTNews (http://www.rttnews.com/2941453/novartis-announces-fda-and-ema-filing-acceptance-of-siponimod.aspx)

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Referenced Symbols: NVS

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