OBJECTIVES: To examine the impact of FDA expedited review programs on new drug approval times and identify key factors associated with expedited approval.

METHODS: All New Drug and Biologic License Applications approved from January 2015 to December 2022 were analyzed. Review times associated with priority review and other expedited programs were compared to standard review with no expedited programs. The relative risk (RR) was calculated for comparisons of interest.

RESULTS: The 360 approvals included priority only (n=13%), priority and ≥1 expedited pathway (52%), standard only (n=30%), and standard and ≥1 expedited pathway (n=5%). Therapies under priority review had a shorter mean (median) review time of 9.4 (8.0) months compared to 18.6 (12.0) months for therapies under standard review only, equating to 9.2 (4.0) months saved. Individually, fast track, breakthrough, and accelerated approval designations had little impact on review time for therapies under priority review, but the combination of priority review, accelerated approval, and breakthrough therapy designations provided the shortest overall mean (median) time to approval: 6.9 (5.9) months. Furthermore, therapies were significantly more likely to be approved during the first review cycle if they underwent priority review (RR=2.44), breakthrough therapy designation (RR=3.43), or fast-track designation (RR=1.96), compared to therapies without the respective designation.

The likelihood of priority review increased for therapies with any expedited designation, with accelerated approval producing the largest impact (RR=32.18) and fast-track designation the smallest (RR=4.02). First-in-class therapies were also significantly more likely than non-first-in-class therapies to receive a priority review (RR=1.39), breakthrough therapy designation (RR=2.01), or fast-track designation (RR=1.34).

CONCLUSIONS: FDA review is shorter and more likely to result in first-round approval if an expedited program designation and/or priority review are applied. The combination of accelerated approval and breakthrough therapy designations was most likely to enable priority review status and facilitate rapid approval.