FDA to Review Siponimod for Secondary Progressive Multiple Sclerosis

Regulatory action is expected sometime in March 2019
Regulatory action is expected sometime in March 2019

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for siponimod (BAF312; Novartis), an investigational oral treatment for secondary progressive multiple sclerosis (SPMS) in adults. 

Siponimod, a selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor, binds to the S1P1 sub-receptor on lymphocytes preventing them from entering the central nervous system (CNS) of MS patients. Preclinical studies have suggested that the treatment may prevent synaptic neurodegeneration and promote remyelination in the CNS.

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The NDA is supported by data from the EXPAND trial, a randomized, double-blind, placebo-controlled Phase 3 study in 1652 participants living with SPMS. Results showed that siponimod significantly reduced the risk of 3-month confirmed disability progression by 21% compared with placebo (P=.013). Moreover, siponimod delayed the risk of 6-month confirmed disability progression (26% vs placebo, P=.0058), according to a Company press release. 

"If approved, siponimod would be the first oral treatment approved for SPMS that significantly delays disability progression," said Fabrice Chouraqui, Novartis Pharmaceuticals Corporation. "We look forward to working with the FDA to make it available to people living with MS as quickly as possible."

For more information visit Novartis.com