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Government drug repurposing can add new uses to existing medicines. This study shows many medicines have evidence for new uses, particularly for rare diseases and children, benefiting patients and neglected populations.

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Area of Science:

  • Pharmaceutical innovation
  • Drug repurposing
  • Regulatory science

Background:

  • Government-led drug repurposing programs are changing pharmaceutical innovation.
  • A proposed European Union (EU) reform grants the European Medicines Agency (EMA) authority to approve new therapeutic indications for marketed drugs without marketing authorization holder consent.
  • This authority is opposed by companies but its potential patient benefit is poorly understood.

Purpose of the Study:

  • To empirically assess the potential of the EMA's new repurposing authority.
  • To analyze the volume and types of evidence-based new uses for existing medicines.
  • To evaluate the implications for neglected patient populations.

Main Methods:

  • Analysis of 198 medicines over 12 years.
  • Comparison of EMA-authorized labels with US Food and Drug Administration (FDA) approvals and off-label use references.
  • Identification of additional therapeutic indications supported by clinical evidence.

Main Results:

  • 67% of analyzed medicines had at least one additional evidence-based use, totaling 320 potential new indications.
  • 39% of these new uses were for new diseases, and 61% were for new patient cohorts.
  • A third of new patient cohort uses involved pediatric populations, highlighting a potential benefit for neglected groups.

Conclusions:

  • The EMA's proposed authority could facilitate the approval of numerous evidence-based drug repurposing uses, especially those already approved by the FDA.
  • The findings support the policy focus on repurposing for new patient cohorts, including pediatric populations.
  • This regulatory power presents a significant opportunity to address unmet medical needs in neglected populations.