Abstract
With the increasing costs of drug development, repurposing of low-cost medicines for new indications has never been more important. However, there are multiple barriers to repurposing, particularly for off-patent medicines, and limited incentives for the pharmaceutical industry to sponsor registration and public subsidy listing. Here, we explore these barriers and their consequences and provide examples of successful repurposing strategies.
Original language | English |
---|---|
Pages (from-to) | 1284-1287 |
Number of pages | 4 |
Journal | Internal Medicine Journal |
Volume | 53 |
Issue number | 7 |
DOIs | |
Publication status | Published - Jul 2023 |
Keywords
- generic
- medicine
- off-label
- off-patent
- repurposing
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In: Internal Medicine Journal, Vol. 53, No. 7, 07.2023, p. 1284-1287.
Research output: Contribution to journal › Article › Other › peer-review
TY - JOUR
T1 - Can old drugs learn new tricks? Achieving registration and public subsidy listing for off-patent medicines with novel therapeutic applications
AU - Brett, Jonathan
AU - Bahceci, Dilara
AU - Lipworth, Wendy
AU - Liknaitzky, Paul
AU - Day, Ric O.
AU - Rodgers, Anthony
N1 - Funding Information: Jonathan Brett was supported by an NHMRC Investigator Grant (ID: 1196560) and the Centre of Research Excellence in Medications Intelligence (ID: 1196900). Open access publishing facilitated by University of New South Wales, as part of the Wiley - University of New South Wales agreement via the Council of Australian University Librarians. Funding Information: Jonathan Brett was supported by an NHMRC Investigator Grant (ID: 1196560) and the Centre of Research Excellence in Medications Intelligence (ID: 1196900). Open access publishing facilitated by University of New South Wales, as part of the Wiley ‐ University of New South Wales agreement via the Council of Australian University Librarians. Funding Information: International examples of successful medicine repurposing by non‐pharmaceutical company organisations include moxidectin, thalidomide and dimethyl fumarate. Moxidectin was discovered in the 1980s and used as a veterinary anti‐helminthic (worming) medicine. It was repurposed by Medicines Development for Global Health, a Melbourne‐based not‐for‐profit organisation, with support from the WHO and funding from the Global Investment Fund. They were awarded FDA priority review vouchers, which were used to expedite review, and proceeds from the sale of vouchers funded medicine development. Ultimately moxidectin was approved in 2018 to treat river blindness caused by Onchocerca, making Medicines Development for Global Health the first not‐for‐profit company in the world to register a medicine with the FDA. Thalidomide was FDA‐approved for treating erythema nodosum leprosum in 1998 based on published and non‐published studies funded by the WHO. Dimethyl fumarate, initially used as a fungicide to prevent the growth of mould on furniture, was subsequently repurposed for the treatment of multiple sclerosis and registered with the FDA in 2013 on the basis of investigator‐driven clinical trials. More recently, psychedelic‐assisted therapies for public good have drawn the support of not‐for‐profit organisations such as the Multidisciplinary Association for Psychedelic Studies (for MDMA) and Usona Institute (psilocybin), which are predominantly philanthropically funded and effectively acting as sponsors for FDA applications. 12 13 7 Publisher Copyright: © 2023 The Authors. Internal Medicine Journal published by John Wiley & Sons Australia, Ltd on behalf of Royal Australasian College of Physicians.
PY - 2023/7
Y1 - 2023/7
N2 - With the increasing costs of drug development, repurposing of low-cost medicines for new indications has never been more important. However, there are multiple barriers to repurposing, particularly for off-patent medicines, and limited incentives for the pharmaceutical industry to sponsor registration and public subsidy listing. Here, we explore these barriers and their consequences and provide examples of successful repurposing strategies.
AB - With the increasing costs of drug development, repurposing of low-cost medicines for new indications has never been more important. However, there are multiple barriers to repurposing, particularly for off-patent medicines, and limited incentives for the pharmaceutical industry to sponsor registration and public subsidy listing. Here, we explore these barriers and their consequences and provide examples of successful repurposing strategies.
KW - generic
KW - medicine
KW - off-label
KW - off-patent
KW - repurposing
UR - http://www.scopus.com/inward/record.url?scp=85164499602&partnerID=8YFLogxK
U2 - 10.1111/imj.16159
DO - 10.1111/imj.16159
M3 - Article
C2 - 37409815
AN - SCOPUS:85164499602
SN - 1444-0903
VL - 53
SP - 1284
EP - 1287
JO - Internal Medicine Journal
JF - Internal Medicine Journal
IS - 7
ER -