Presentation (CTI)

OBJECTIVES: While the FDA strives to meet specific review cycle goals when reviewing new drug applications (NDA) and biologic license applications (BLA), the actual time between NDA/BLA submission and final FDA decision can vary. This analysis seeks to examine the potential relationship between FDA review duration and the following factors: molecule type, therapeutic area, FDA-granted designations (e.g. fast track status, breakthrough therapy), and notable milestones (first-in-class, first-in-country). We focus on novel drugs approved between 2019 and 2024 to explore these associations.
METHODS: We included novel small molecule, therapeutic biologics, and cell and gene therapies. Vaccines and products intended for use in diagnostic processes were excluded. Data were primarily obtained via the FDA website and validated using a two-coder system. Descriptive and regression analyses were conducted.
RESULTS: Preliminary analyses from the 2019 cohort confirm that applications granted priority review have a significantly shorter review cycle than applications assigned standard review (median 240 days versus 365 days, P < 0.001). However, applications granted priority review that also have breakthrough therapy designation (alone or in combination with other FDA-granted designations), appeared to be shorter. Future analyses will examine these relationships further and analyze temporal patterns across the full 2019-2024 dataset.
CONCLUSIONS: Understanding the impact of these pre-submission factors on the duration of the FDA review cycle may benefit health technology assessment organizations and other stakeholders interested in estimating the timelines of drugs in the late stages of development.