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Area of Science:

  • Neuroscience
  • Pharmacology

Background:

  • Siponimod is an oral selective sphingosine 1-phosphate receptor subtypes 1 and 5 (S1PR1,5) modulator.
  • It is developed by Novartis Pharmaceuticals for treating multiple sclerosis (MS) and intracerebral hemorrhage.

Purpose of the Study:

  • To summarize the development milestones of siponimod.
  • To highlight its first global approval for multiple sclerosis (MS) in the USA.

Main Methods:

  • Review of siponimod's development process.
  • Analysis of regulatory submissions and approvals.

Main Results:

  • Siponimod received its first global approval in the USA in March 2019.
  • Approval is for adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Conclusions:

  • Siponimod's approval represents a significant advancement in MS treatment.
  • The drug is also under regulatory review for secondary progressive MS in the EU and Japan.