Penetrating the CNS – Strategic Implications of an Increasingly Flexible FDA

Central Nervous System (CNS) drug development ranks among the lowest in terms of likelihood of approval and among the highest in terms of drug approval timelines. Thankfully, recent Food and Drug Administration (FDA) approvals reflect an increased openness towards regulatory concessions for CNS therapeutic candidates, as exemplified by an uptick in fast-track, breakthrough therapy, accelerated approval, and priority review designations, along with approvals based on a single pivotal trial. But what does this mean for CNS-focused biopharma companies, and how can they benefit from shared learnings across this topic to make the best use of scarce resources and bring novel therapeutic solutions to patients in need?

Read our paper for some quick CNS drug development strategy takeaways supported by recent examples of US approvals based on FDA flexibility.