EMA’s Adaptive Pathway Pilot Hits Benchmark, Moves to Formalization

After nearly two years, the EMA is formalizing its iterative pathway program that saw six applications progress to formal advice from the agency, according to a report.

In total, the agency received 62 applications for inclusion in its adaptive pathway pilot, which provided a new approval route for therapies focusing on unmet needs by allowing real world evidence to supplement randomized clinical trials.

An EMA report and guidance on adaptive pathways both clarify the purpose of the program, which mystified many of the original applicants whose submissions were better suited for traditional approval routes.