There has been much discussion about the lengthy and expensive development pathway for bringing new medicines to the market; maybe the time has come for a paradigm shift?

The European Medicines Agency (EMA) has recently released information on the use of adaptive pathways to expedite the drug development pathway. The idea behind this novel approach is to approve a new medicine in a restricted patient population based on efficacy in early clinical trials.

This initial approval would be followed by expansion into broader patient populations as additional supportive data becomes available.

The chief drivers for using this different approach includes:

  • Enabling patient’s timely access to new medicines especially where there is an unmet medical need.
  • Understanding of the pathologies which enable the identification of patient subgroups most likely to respond to the new treatment
  • Importance of a targeted approach thus prescribing drugs to patients whom are most likely to benefit

The adaptive pathway should also improve the sustainability of the pharmaceutical industry and enable more patients to benefit from innovative therapies.

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