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Innovative Pediatric Development for Secukinumab in Psoriasis: Faster Patient Access, Reduction of Patients on

Ruquan You1, Sebastian Weber2, Bruno Bieth2

  • 1Analytics, Novartis Institutes for Biomedical Research, Shanghai, China.

Clinical Pharmacology and Therapeutics
|December 23, 2021
PubMed

Insights

Innovative quantitative methods accelerated secukinumab

Area of Science:

  • Pharmacology and Therapeutics
  • Pediatric Dermatology
  • Regulatory Science

Background:

  • Pediatric drug development is legally mandated but historically complex.
  • Early development of secukinumab for pediatric psoriasis faced challenges due to limited data and nascent extrapolation frameworks.
  • A standard program with multiple placebo-controlled trials was initially proposed.

Purpose of the Study:

  • To describe the innovative pediatric development strategy for secukinumab in psoriasis.
  • To detail the implementation of quantitative approaches to accelerate pediatric drug approval.
  • To showcase the successful application of extrapolation and other novel techniques.

Main Methods:

  • Utilized innovative quantitative techniques, including extrapolation frameworks.
  • Adapted the pediatric development plan based on growing experience and regulatory acceptance of novel methods.
  • Implemented a revised strategy to reduce trial size and duration.

Main Results:

  • Successfully removed the placebo arm from one pivotal trial.
  • Achieved a substantial reduction in the overall sample size for the pediatric program.
  • Significantly expedited the approval of secukinumab for pediatric psoriasis patients.

Conclusions:

  • Innovative quantitative strategies, such as extrapolation, can significantly optimize pediatric drug development.
  • This approach led to faster regulatory approval and reduced trial burden.
  • The strategy demonstrates a successful model for accelerating pediatric access to novel therapies.

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