221
views
0
recommends
+1 Recommend
1 collections
    0
    shares
      scite_
       
      • Record: found
      • Abstract: found
      • Conference Proceedings: found
      Is Open Access

      Label extensions: Benefits and challenges for drug repurposing

      Published
      conference-abstract
        1 ,
      RExPO23 Conference
      REPO4EU
      RExPO23
      25-26 October 2023
      Drug repurposing, approved, generic, market authorization, label extension, variation, reimbursement, patients, patient access
      Bookmark

            Abstract

            Drug repurposing of approved drugs, generic as well as those still on-patent, has tremendous untapped potential to bring new treatments to patients with unmet needs. While preclinical and clinical strategies for assessing the efficacy and safety of drug repurposing candidates are becoming increasingly sophisticated and well supported, the final steps for entry into clinical practice remain uncertain. While in some regulatory jurisdictions off-label usage of approved drugs is possible, at least to a certain extent, in other regulatory jurisdictions off-label usage is difficult and/or not reimbursed. This talk will discuss benefits as well as challenges in extending drug labels to include expanded indications as the most effective path towards patient access to repurposed drugs.

            Content

            Author and article information

            Conference
            RExPO23 Conference
            REPO4EU
            3 October 2023
            Affiliations
            [1 ] REMEDi4ALL / EATRIS;
            Author notes
            Author information
            https://orcid.org/0009-0005-0369-5789
            Article
            10.58647/REXPO.23000020.v1
            3fec2fd2-255b-4bf0-a89c-73f6b60a1466

            This work has been published open access under Creative Commons Attribution License CC BY 4.0 , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Conditions, terms of use and publishing policy can be found at www.scienceopen.com .

            RExPO23
            2
            Stockholm, Sweden
            25-26 October 2023
            History
            : 3 October 2023
            Funding
            Funded by: funder-id http://dx.doi.org/10.13039/100019180, HORIZON EUROPE European Research Council;
            Award ID: 101057442
            Categories

            Data sharing not applicable to this article as no datasets were generated or analysed during the current study.
            Medicine
            Drug repurposing,approved,generic,market authorization,label extension,variation,reimbursement,patients,patient access

            Comments

            Comment on this article