Van doorontwikkeling van een geneesmiddel tot registratie-uitbreiding

Continued development of existing drugs (‘drug rediscovery’) may offer new therapeutic options and be cost-effective. Rediscovered drugs are commonly prescribed off-label, although licensing can be important to allow safe and controlled prescription of the drugs to patients. Licensing of a new indication for a generic drug, however, is a complicated process since there is no blueprint for this and there is little interest from the pharmaceutical industry due to an unattractive cost-recovery model. In this article, we illustrate the successful license-extension for thioguanine – initially developed in 1950 for leukaemia – as a new treatment for patients with inflammatory bowel disease.

Conflict of interest and financial support for this article: the Department of Gastroenterology and Hepatology of the VU Medical Center, Amsterdam, the Netherlands, has received an unrestricted research grant by Teva Pharma BV for conducting research on thioguanine in inflammatory bowel disease. Additional potential conflicts of interest have been reported. ICMJE forms provided by the authors are available online along with the full text of this article.