Fast-track drug approval in inflammatory bowel diseases.

ABSTRACT

Fast-track drug designation of safe regimens represents an emerging method of development and approval of new medications targeting debilitating diseases including inflammatory bowel diseases (IBD). The goal of accelerated drug approval pathways is to shorten the time between application and approval of therapies that treat diseases with significant morbidity and mortality. Recently, fast-track drug approval approaches were supported by data deriving from central reading of images, a method of clinical data interpretation that has significantly benefited patients with gastrointestinal disorders. Biological agents and other emerging therapies in IBD represent "game-changing" or "treat-to-target" drugs and have satisfied quite successfully some of the patients' unmet needs. The development of biosimilars is an area where the Federal Drug Administration and the European Agency for Evaluation of Medicinal Products seem to have different approval processes. Biosimilars, including those for IBD, promise cost reductions and wide access to biologic therapies by patients, advantages similar to those already offered by generic drugs. Given the rapid development of IBD drugs and patients' needs, a consensus among the academic community, clinicians, researchers, sponsors, patients and regulatory authorities is required to standardize better the IBD trials and create a productive environment for fast-track approval of any "changing-game" IBD drug.