Thursday, 12 February 2015

Adaptive pathways for drug development

Adaptive pathways should be the preferred approach in the near future to bring new medicines to patients according to the European Medicines Agency (EMA).

This has been outlined in an article published in Clinical Pharmacology and Therapeutics. The concept of adaptive pathways foresees an early approval of a medicine for a restricted patient population based on small initial clinical studies.

The first approval is followed by progressive adaptations of the marketing authorisation to expand access to the medicine to broader patient populations based on data gathered from its use and additional studies.

EMA launched a pilot project on adaptive pathways (formerly known as adaptive licensing) in March 2014 to explore this approach with real medicines in development.

As of November 2014, the Agency had received and assessed 29 applications as part of the pilot, nine of which had been selected for discussion with the applicant.

For further details, see EMA

Posted by Tim Sandle