EMA keeps approval speedway open
After a two-year pilot period, the EMA has published its report on its adaptive pathways approach. The agency plans to explore the concept further and will continue to accept proposals.
The European Medicines Agency (EMA) has published a final report on the experiences with its new accelerated route to approval for innovative drugs, the adaptive pathways.
The pilot project, which has now ended, showed that adaptive pathways can bring multiple stakeholders together – regulators, health technology assessment (HTA) bodies, healthcare professionals and patients – to agree on a prospective plan to generate data on a medicine across its lifespan in areas of unmet medical need, the EMA stated. Adaptive pathways can support medicine development in therapeutic areas where evidence generation is challenging, such as infectious diseases, Alzheimer’s disease, degenerative diseases, and rare cancers.
The project phase was launched in 2014. Since then, 62 companies applied with a product to be included. However, only 18 met the EMA’s criteria for inclusion, and no more than six progressed to receive formal parallel advice by EMA and HTA bodies. The adaptive pathways concept is still under development, the EMA pointed out. It has announced a workshop to gather the views from stakeholders, which will take place in December.
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T. Rowe Price
Sandoz
Tenthpin Solutions AG