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<p>Despite infectious diseases being a significant threat to global health, there are continuing concerns that regulatory authorities do not prioritize therapeutic strategies for infectious diseases with the same urgency as those for oncological or orphan diseases. This study aims to examine the differences in the productivity of drug development and approval procedures between non-infectious and infectious diseases, and to determine the utilization patterns of acceleration programs. All molecules and biologic products approved between January 1, 2015, and December 31, 2024 (N = 464) were subject to a cross-sectional study. Drugs@FDA, the Federal Register, and ClinicalTrials.gov were used as sources of data to establish median Clinical Development Time (CDT), Regulatory Approval Time (RAT), and cumulative Regulatory Review Time (RRT). Kruskal–Wallis tests were used to compare median values (interquartile range, IQR), and chi-square tests were used for proportions. Time-to-event differences were tested using Kaplan–Meier analyses with log-rank testing, and hazard ratios (HRs) were calculated using Cox proportional hazards models. Multivariable logistic regression with interaction terms was used to model Priority Review, Fast Track, Breakthrough Therapy, and Accelerated Approval, reporting adjusted odds ratios (aOR). Of 464 approvals, 65 (14.0%) targeted infectious diseases. Median CDT was 2.76&#xa0;years (IQR&#xa0;1.80–4.25) versus 3.46&#xa0;years (IQR&#xa0;2.59–4.66; <i>p</i> = 0.003), and median RRT was 3.54&#xa0;years (IQR&#xa0;2.58–5.03) versus 4.22&#xa0;years (IQR&#xa0;3.24–5.73; <i>p</i> = 0.006) for infectious and non‑infectious drugs, respectively. Nevertheless, infectious agents were approved 58% faster (HR = 1.58; 95%&#xa0;CI 1.15–2.16; <i>p</i> = 0.0047). Infectious disease products were more likely to receive Fast Track (OR = 4.49; 95%&#xa0;CI 2.39–8.70) and Priority Review (OR = 10.69; 95%&#xa0;CI 4.57–29.50) but less likely to obtain Breakthrough Therapy (OR = 0.42; 95%&#xa0;CI 0.28–0.63) or Accelerated Approval (OR = 0.12; 95%&#xa0;CI 0.016–0.56). Infectious disease treatments outpace non-infectious disease treatments in terms of drug development and approval timelines. Nevertheless, they are less frequently utilized in pathways like Accelerated Approval, which are scientifically less applicable to acute-disease endpoints. Therefore, policy reforms should focus on addressing the underlying economic and scientific barriers to anti-infective innovation.</p>

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Regulatory alignment in FDA expedited pathways for infectious diseases: a decadal review with predictive modeling insights

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年12月13日

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  • Nguyen Thanh Tam,
  • Ahmed M. Sayed,
  • Mohammad Najm Dadam,
  • Randa Elsheikh,
  • Jeza Muhammad Abdul Aziz,
  • Abdelrahman Gamil Gad,
  • Thi Thu Hoai Nguyen,
  • Phillip Tran,
  • Zhilin Zhang,
  • Norio Ohmagari,
  • Nguyen Tien Huy

摘要

Despite infectious diseases being a significant threat to global health, there are continuing concerns that regulatory authorities do not prioritize therapeutic strategies for infectious diseases with the same urgency as those for oncological or orphan diseases. This study aims to examine the differences in the productivity of drug development and approval procedures between non-infectious and infectious diseases, and to determine the utilization patterns of acceleration programs. All molecules and biologic products approved between January 1, 2015, and December 31, 2024 (N = 464) were subject to a cross-sectional study. Drugs@FDA, the Federal Register, and ClinicalTrials.gov were used as sources of data to establish median Clinical Development Time (CDT), Regulatory Approval Time (RAT), and cumulative Regulatory Review Time (RRT). Kruskal–Wallis tests were used to compare median values (interquartile range, IQR), and chi-square tests were used for proportions. Time-to-event differences were tested using Kaplan–Meier analyses with log-rank testing, and hazard ratios (HRs) were calculated using Cox proportional hazards models. Multivariable logistic regression with interaction terms was used to model Priority Review, Fast Track, Breakthrough Therapy, and Accelerated Approval, reporting adjusted odds ratios (aOR). Of 464 approvals, 65 (14.0%) targeted infectious diseases. Median CDT was 2.76 years (IQR 1.80–4.25) versus 3.46 years (IQR 2.59–4.66; p = 0.003), and median RRT was 3.54 years (IQR 2.58–5.03) versus 4.22 years (IQR 3.24–5.73; p = 0.006) for infectious and non‑infectious drugs, respectively. Nevertheless, infectious agents were approved 58% faster (HR = 1.58; 95% CI 1.15–2.16; p = 0.0047). Infectious disease products were more likely to receive Fast Track (OR = 4.49; 95% CI 2.39–8.70) and Priority Review (OR = 10.69; 95% CI 4.57–29.50) but less likely to obtain Breakthrough Therapy (OR = 0.42; 95% CI 0.28–0.63) or Accelerated Approval (OR = 0.12; 95% CI 0.016–0.56). Infectious disease treatments outpace non-infectious disease treatments in terms of drug development and approval timelines. Nevertheless, they are less frequently utilized in pathways like Accelerated Approval, which are scientifically less applicable to acute-disease endpoints. Therefore, policy reforms should focus on addressing the underlying economic and scientific barriers to anti-infective innovation.