Label extensions: Benefits and challenges for drug repurposing

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.