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Label extension

In silico clinical trial to support label extension.

Background

The Sponsor has considered the request of a label extension for a drug which is currently used off-label in MS patients.

Question of Interest

Could modeling and simulation provide evidence that off-label administration delays disease progression without impacting safety parameters? 

Methods

An in silico clinical trial was conducted using an agent-based model of innate and adaptive immune system as well as MS disease progression.

Results

Simulations confirmed the efficacy and safety of the off-label administration in virtual MS patients.    

Impact

  •  The Sponsor included the in silico evidence into the dossier requesting label extension to regulatory body.
  • The Sponsor intends to publish the analysis results in a peer-reviewed journal.
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