Drug Lag and Associated Factors for Approved Drugs in Korea Compared with the United States
Abstract
:1. Introduction
2. Materials and Methods
2.1. Data Collection
2.2. Study Drugs
2.3. Variables
2.3.1. Dependent Variable
2.3.2. Independent Variables
2.3.3. Statistical Analysis
3. Results
3.1. Associations with the Drug Lag and Related Factors
3.2. Association of the Potential Delaying Factors of the Local Study on Drug Lag
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Data Availability Statement
Conflicts of Interest
References
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Category | n | % |
---|---|---|
Total drugs approved during 2000–2019 | ||
Total drugs investigated | 424 | 100 |
Category | ||
Chemical drugs | 316 | 74.5 |
Biologics | 108 | 25.5 |
Nationality of pharmaceutical company for drug development | ||
US | 145 | 34.2 |
Europe (including Switzerland) | 233 | 55.0 |
Japan | 36 | 8.5 |
Others | 10 | 2.4 |
Nationality of Marketing Authorization Holder (MAH) | ||
Korea pharmaceutical company | 57 | 13.4 |
Multinational pharmaceutical company | 367 | 86.6 |
Orphan Drug Designation Status (by Ministry of Food and Drug Safety, Korean Health Authority) | ||
Yes | 147 | 34.7 |
No | 277 | 65.3 |
Regulatory pathway in US | ||
Orphan drug designation | 110 | 25.9 |
Priority review | 170 | 40.1 |
Orphan drug designation and priority review | 49 | 11.6 |
Oncology drugs | ||
Yes | 136 | 32.1 |
No | 288 | 67.9 |
Therapeutic indication (Anatomical Therapeutic Classification code) | ||
A (Alimentary tract and metabolism) | 50 | 11.8 |
B (Blood and blood forming organs) | 27 | 6.4 |
C (Cardiovascular system) | 16 | 3.8 |
D (Dermatology) | 5 | 1.2 |
G (Genito-urinary system and sex hormones) | 15 | 3.5 |
H (Systemic hormonal preparations, excluding sex hormones) | 10 | 2.4 |
J (Anti-infectives for systemic use) | 68 | 16.0 |
L (Antineoplastic and immunomodulatory agents) | 143 | 33.7 |
M (Musculoskeletal system) | 6 | 1.4 |
N (Nervous system) | 29 | 6.8 |
P (Antiparasitic products, insecticides, and repellents) | 1 | 0.2 |
R (Respiratory system) | 18 | 4.2 |
S (Sensory organs) | 14 | 3.3 |
V (Various) | 22 | 5.2 |
Variable (n = 424) | Hazard Ratio (95% Confidence Interval) | p-Value |
---|---|---|
Regulatory pathway in Korea | ||
New drug review by Ministry of Food and Drug Safety | Reference | |
Orphan drug review by Ministry of Food and Drug Safety | 0.731 (0.572–0.934) | 0.0121 |
Nationality of the Marketing authorization holder (MAH) | ||
Non-Korean Company | Reference | |
Korean Company | 0.524 (0.371–0.738) | 0.0002 |
Drug characteristics—Type of drug | ||
Chemical Drugs | Reference | |
Biological Drugs | 1.068 (0.816–1.397) | 0.6314 |
Drug characteristics—Therapeutic area | ||
Non-oncology Drugs | Reference | |
Oncology Drugs | 1.055 (0.848–1.313) | 0.6311 |
Nationality of pharmaceutical company for drug development | ||
US | Reference | |
Europe (including Switzerland) | 1.031 (0.824–1.291) | 0.7883 |
Japan | 0.858 (0.576–1.276) | 0.4486 |
Others | 0.824 (0.423–1.603) | 0.5682 |
Regulatory pathway in US | ||
Standard review by US Food and Drug Administration | Reference | |
Priority review by US Food and Drug Administration | 0.938 (0.736–1.195) | 0.6032 |
Approval year by Ministry of Food and Drug Safety | ||
Approved drugs before 2015 | Reference | |
Approved drugs since 2015 | 2.02 (1.526–2.672) | <0.0001 |
R2 | 0.1542 |
Variable (n = 37) | Hazard Ratio (95% Confidence Interval) | p-Value |
---|---|---|
Development lag from the initial clinical study to approval date of the drug | 0.97 (0.942–0.999) | 0.0421 |
Drug characteristics—Type of drug | ||
Chemical Drugs | Reference | |
Biological Drugs | 0.87 (0.29–2.605) | 0.8029 |
Drug characteristics—Therapeutic area | ||
Non-oncology Drugs | Reference | |
Oncology Drugs | 0.247 (0.093–0.657) | 0.0051 |
Nationality of pharmaceutical company for drug development | ||
US | Reference | |
Europe (including Switzerland) | 1.62 (0.643–4.081) | 0.3059 |
Japan | 1.162 (0.229–5.895) | 0.8566 |
Regulatory pathway in US | ||
Standard review by US Food and Drug Administration | Reference | |
Priority review by US Food and Drug Administration | 0.921 (0.317–2.674) | 0.88 |
Number of clinical studies in Korea | 2.133 (1.196–3.805) | 0.0103 |
Number of Korean patients participating in clinical studies in Korea | 0.993 (0.988–0.999) | 0.0172 |
R2 | 0.3702 |
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Cho, I.; Han, E. Drug Lag and Associated Factors for Approved Drugs in Korea Compared with the United States. Int. J. Environ. Res. Public Health 2022, 19, 2857. https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph19052857
Cho I, Han E. Drug Lag and Associated Factors for Approved Drugs in Korea Compared with the United States. International Journal of Environmental Research and Public Health. 2022; 19(5):2857. https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph19052857
Chicago/Turabian StyleCho, Inhye, and Euna Han. 2022. "Drug Lag and Associated Factors for Approved Drugs in Korea Compared with the United States" International Journal of Environmental Research and Public Health 19, no. 5: 2857. https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph19052857