Novartis’ MS drug Siponimod has been filed for review with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
The drug is an investigational, selective modulator of specific sphingosine-1-phosphate (S1P) receptor subtypes that is designed to treat adults with secondary progressive multiple sclerosis (SPMS).
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SPMS is a type of multiple sclerosis (MS) that results in irreversible disability. Patients with the disease often experience bladder dysfunction and cognitive decline, and require walking aids or wheelchairs.
Siponimod binds to S1P1 sub-receptors on lymphocytes, preventing their entry into the central nervous system (CNS) and causing anti-inflammatory effects. It also binds to the S1P5 sub-receptor on oligodendrocytes and astrocytes within the CNS, which is expected to help regulate cell activity.
Novartis Pharmaceuticals’ CEO Paul Hudson said: “Siponimod is the first investigational medicine to show a significant delay in disability progression in typical SPMS patients.
“With siponimod, we underpin our strong commitment to the MS community by reimagining care for people whose lives have been considerably disrupted by this devastating illness.”
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By GlobalDataThe regulatory applications contain results from a randomised, double-blind, placebo-controlled Phase III EXPAND trial, which was conducted to compare the safety and efficacy of Siponimod with placebo.
The findings revealed a decreased risk of three-month and six-month confirmed disability progression with Siponimod treatment.
Data also showed favourable outcomes in other relevant MS disease activity and progression measures.
Novartis used a review voucher to accelerate the review of Siponimod in the US. The company expects regulatory action from the FDA in March next year and from the EMA late next year.
In Switzerland, Siponimod secured fast-track authorisation procedure in SPMS from Swissmedic.
