Regulatory perspective of Drug Repurposing: Methods, Regulatory pathways and Hurdles
Abstract
Drug repurposing is a phenomenon that aims at utilising an established and approved drug product or drug substance for an additional clinical indication apart from the one that it was intended for. The reprofiling of drug formulations creates an extensive arsenal of therapeutic options for drug products, thus making the practice a desirable and forthcoming procedure. There are several techniques and methods that have been adopted over the years to evaluate the various possibilities for the repurposing of drugs in search of a wider range of chemical therapeutics.
The repurposing of drug products has provided, over the course of time several different advantages to the pharmaceutical industry, and yet remains an uncomprehended and over-looked procedure. The following paper attempts to identify the different benefits that are to be gained from the repurposing of drug products along with the approaches that have been used for the same. Additionally, the paper also discusses the regulatory perspective of drug repurposing, emphasising on the incentives that are available for various pharmaceutical sponsors as well the hurdles that are to be faced during the repurposing of a drug product or drug substance.
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References
https://www.wipo.int/wipo_magazine/en/2020/02/article_0004.html
2. Hernandez JJ, Pryszlak M, Smith L, et al. Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs as Cancer Therapeutics [Internet]. Front. Oncol.; 2017Nov [cited 2022 April 22]. 7(273). Available from:
https://www.frontiersin.org/articles/10.3389/fonc.2017.00273/full
3. Rudrapal M, Khairnar SJ, Jadhav AG. Drug Repurposing (DR): An Emerging Approach in Drug Discovery. In: Badria, F. A., editor. Drug Repurposing - Hypothesis, Molecular Aspects and Therapeutic Applications [Internet]. London: IntechOpen; 2020 [cited 2022 April 22]. Available from:
https://www.intechopen.com/chapters/72744
4. Parvathaneni V, Kulkarni NS, Muth A, Gupta V, Drug Repurposing: A Promising Tool to Accelerate the Drug Discovery Process. Drug Discovery Today [Internet]. 2019 [cited 2022 April 22]; 24(10):2076-2085. Available from:
https://pubmed.ncbi.nlm.nih.gov/31238113/
5. Talevi A, Bellera CL et al. Challenges And Opportunities With Drug Repurposing: Finding Strategies to find Alternative uses of Therapeutics, Expert Opinion on Drug Discovery [Internet]. 2020 [cited 2022 April 22]; 15(4): 397-401. Available from:
https://pubmed.ncbi.nlm.nih.gov/31847616/
6. Li J, Zheng Si, Chen B, Butte AJ, Swamidass SJ, Lu Z , A Survey Of Current Trends In Computational Drug Repositioning, Briefings In Bioinformatics [Internet]. 2016 [cited 2022 April 22]. 17(1):2–12. Available from:
https://academic.oup.com/bib/article/17/1/2/2240099
7. Alasdair B, Robin J, Overcoming The Legal And Regulatory Barriers To Drug Repurposing. Nature Reviews Drug Discovery [Internet]. 2018 [cited 2022 April 22]; 18(1): 1-2. Available from:
https://pubmed.ncbi.nlm.nih.gov/29880920/
8. Allison M, NCATS Launches Drug Repurposing Program, Nat Biotechnol [Internet]. 2012 [cited 2022 April 22]; 30(7): 571–572. Available from:
https://pubmed.ncbi.nlm.nih.gov/22781662/
9. Sahragardjoonegani B, Beall RF, Kesselheim AS et al. Repurposing Existing Drugs for New Uses: A Cohort Study of The Frequency Of FDA-Granted New Indication Exclusivities Since 1997. J of Pharm Policy and Pract [Internet]. 2021 [cited 2022 April 22]; 14(3). Available from: https://joppp.biomedcentral.com/articles/10.1186/s40545-020-00282-8
10. Pushpakom S; Iorio F, Eyers PA, Escott KJ, Hopper S, Wells A, Doig A, Guilliams T, et al. Drug Repurposing: Progress, Challenges And Recommendations. Nature Reviews Drug Discovery [Internet]. 2019 [cited 2022 April 22]; 18(1):41-58. Available from:
https://pubmed.ncbi.nlm.nih.gov/30310233/
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