Repositioning: new therapeutic indications for known products10-03-2016
In the last five years, 30% of marketing authorizations issued by the FDA were for existing drugs, and it is estimated that there are over 2,000 products which may be subject to repositioning in drug libraries, a number that is growing with 150 – 200 drugs that are abandoned every year.
It is a well-known fact that some drugs prescribed for a second indication have become a significant source of income for the companies that marketed them.
Repositioning strategies can be useful both to increase the life cycle of authorized and marketed medications through the search of new indications or fomulations, and to retrieve those drugs that were abandoned during the clinical phases or even after being marketed, whether because expected results regarding efficacy or safety in patients were not achieved or for strategic and/or commercial reasons.
Having been subject to a clinical trial, repositioned products already have a known safety profile, in some cases in the long term, so the investment and time required to obtain a marketing authorization are significantly lower than with a de novodiscovery and development of a drug.
In this sense,repositioned drugs are estimated to have a three-to-five-year decrease in time of development, and the likelihood of success in obtaining a marketing authorization increases by 15%.
Furthermore, the clinical development of existing drugs for use in new indications may entail marketing exclusivity rights that are independent from industrial property rights derived from patents, like in the case of products that have never been authorized before (abandoned during the clinical phase) or medications for the treatment of orphan diseases or those targeting pediatric populations.