Accelerated Pathways (APs) for the development of new drugs have multiplied in recent years and have proven to present opportunities and benefits for patients and developers. But the varied nature and diversity of the accelerated pathways in these jurisdictions are generating new, unanticipated challenges that sponsors need to understand and plan for strategically.
In general, APs in all three regions offer the opportunity for shorter clinical development and/or review times, meaning that drugs can reach markets and patients faster, and developers can generate earlier revenue streams to invest in future research, as well as support necessary post-approval clinical and real-world evidence (RWE) collection, while gaining (in many cases) first-to-market competitive advantages.
The similarities among the opportunities and benefits provided by APs in the U.S., Europe, and Japan, come along with important differences. That, combined with varied pre-approval data requirements for different AP pathways in different jurisdictions, and a growing number of involved stakeholders focusing on the risks and benefits of new products, is adding unanticipated complexity to an already tortuous road to market for new drugs.