Scientific Online Resource System

Annual for Hospital Pharmacy

Exploring Drug Repositioning: A Comprehensive Review Of Clinical, Regulatory, And Marketing Strategies

Antonio Ivanov, Ines Hababa, Violeta Getova-Kolarova, Ilko Getov

Abstract

Drug repositioning, a widely adopted strategy, involves the exploration of new indications for investigational or already authorized medicinal products. This approach leverages clinical, regulatory, and marketing tactics to expand a drug's utility. From a clinical perspective, repositioning offers novel insights into addressing significant public health concerns through established drugs. Regulatory agencies support this strategy by streamlining marketing authorization processes, reducing data requirements, and waiving fees. For pharmaceutical companies, repositioning represents an opportunity to develop blockbuster drugs, saving both time and resources while boosting sales and profits. The integration of digital technologies has proven particularly valuable in screening vast numbers of molecules and diseases, uncovering unexpected therapy effects, and identifying candidates for repositioning, thus accelerating the discovery of new treatments. The aim of this study is to distinguish the advantages and objectives of repositioning while analyzing historical milestones and current trends within each this approach of repositioning.


Keywords

repurposing, drug regulation, marketing, drug lifecycle, digitalization

Full Text


References

Hernandez JJ, Pryszlak M, Smith L, Yanchus C, Kurji N, Shahani VM, et al. Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics. Front Oncol. 2017 Nov 14;7:273.

Drug repositioning: a brief overview - PMC [Internet]. [cited 2023 May 10]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7262062/

The rise, fall and subsequent triumph of thalidomide: lessons learned in drug development - Waqas Rehman, Lisa M. Arfons, Hillard M. Lazarus, 2011 [Internet]. [cited 2023 May 17]. Available from: https://journals.sagepub.com/doi/full/10.1177/2040620711413165

Sheskin J. Thalidomide in the treatment of lepra reactions. Clinical Pharmacology & Therapeutics. 1965;6(3):303–6.

D’Amato RJ, Loughnan MS, Flynn E, Folkman J. Thalidomide is an inhibitor of angiogenesis. Proc Natl Acad Sci U S A. 1994 Apr 26;91(9):4082–5.

Singhal S, Mehta J, Desikan R, Ayers D, Roberson P, Eddlemon P, et al. Antitumor Activity of Thalidomide in Refractory Multiple Myeloma. N Engl J Med. 1999 Nov 18;341(21):1565–71.

Holstein SA, McCarthy PL. Immunomodulatory drugs in multiple myeloma: mechanisms of action and clinical experience. Drugs. 2017 Apr;77(5):505–20.

Thalidomide and its analogues in the treatment of Multiple Myeloma | Experimental Hematology & Oncology | Full Text [Internet]. [cited 2023 Apr 28]. Available from: https://ehoonline.biomedcentral.com/articles/10.1186/2162-3619-1-27

Pushpakom S, Iorio F, Eyers PA, Escott KJ, Hopper S, Wells A, et al. Drug repurposing: progress, challenges and recommendations. Nat Rev Drug Discov. 2019 Jan;18(1):41–58.

EMA. COVID-19: developers of medicines or vaccines to benefit from free scientific advice [Internet]. European Medicines Agency. 2020 [cited 2023 Apr 2]. Available from: https://www.ema.europa.eu/en/news/covid-19-developers-medicines-vaccines-benefit-free-scientific-advice

EMA. Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia [Internet]. European Medicines Agency. 2021 [cited 2023 Apr 2]. Available from: https://www.ema.europa.eu/en/news/repurposing-authorised-medicines-pilot-support-not-profit-organisations-academia

Validating drug repurposing signals using electronic health records: a case study of metformin associated with reduced cancer mortality | Journal of the American Medical Informatics Association | Oxford Academic [Internet]. [cited 2023 May 10]. Available from: https://academic.oup.com/jamia/article/22/1/179/833449?login=false

Drug Target Identification Using Side-Effect Similarity | Science [Internet]. [cited 2023 May 10]. Available from: https://www.science.org/doi/10.1126/science.1158140

PREDICT: a method for inferring novel drug indications with application to personalized medicine | Molecular Systems Biology [Internet]. [cited 2023 May 10]. Available from: https://www.embopress.org/doi/full/10.1038/msb.2011.26

download.pdf [Internet]. [cited 2023 Apr 3]. Available from: https://www.fda.gov/media/138725/download

Scannell JW, Blanckley A, Boldon H, Warrington B. Diagnosing the decline in pharmaceutical R&D efficiency. Nat Rev Drug Discov. 2012 Mar;11(3):191–200.

Nosengo N. Can you teach old drugs new tricks? Nature. 2016 Jun 1;534(7607):314–6.

Press Release Archive | Celgene Corporation [Internet]. [cited 2023 Apr 26]. Available from: https://ir.celgene.com/press-releases-archive/default.aspx

What Is Macular Degeneration? [Internet]. American Academy of Ophthalmology. 2023 [cited 2023 Apr 21]. Available from: https://www.aao.org/eye-health/diseases/amd-macular-degeneration

Comparison of Anti-VEGF Treatments for Wet AMD [Internet]. American Academy of Ophthalmology. 2020 [cited 2022 Aug 29]. Available from: https://www.aao.org/eye-health/diseases/avastin-eylea-lucentis-difference

Белчева, В., Е. Насева, Е. Григоров, Т. Златанова. Проучване за информираността на пациентите в България по отношение процеса на прекласификация на лекарствата от гледна точка на безопасност и ефективност /първа част/. Здравна политика и мениджмънт (ISSN 1313-4981), 2017 (17), No.1, с.18-20.

Белчева, В., Е. Насева, Е. Григоров, Т. Златанова. Проучване за информираността на пациентите в България по отношение процеса на прекласификация на лекарствата от гледна точка на безопасност и ефективност /втора част/. Здравна политика и мениджмънт (ISSN 1313-4981), 2017 (17), No.2, с.16-19.




DOI: http://dx.doi.org/10.14748/ahp.v9i1.9073

Refbacks

|