A comprehensive regulatory framework to address the unmet need for new antibacterial treatments

作者：Rex John H^*; Eisenstein Barry I; Alder Jeff; Goldberger Mark; Meyer Robert; Dane Aaron; Friedland Ian; Knirsch Charles; Sanhai Wendy R; Tomayko John; Lancaster Cindy; Jackson Jennifer

来源：Lancet Infectious Diseases, 2013, 13(3): 269-275.

DOI：10.1016/S1473-3099(12)70293-1

To bring new antibacterial drugs to the market is challenging because discovery of new agents is difficult, two large trials per indication are needed in accordance with traditional regulatory requirements, and the economic reward is limited if the use of new antibiotics is constrained. These challenges have resulted in an alarmingly thin antibiotic pipeline, despite the rapid and continued growth in the need for new drugs. Approaches that balance the quantity of data needed for registration with the unmet medical need would encourage work in this are Therefore, a tiered regulatory framework that allows either disease-based or pathogen-based label indications is proposed, with label wording that promotes the most appropriate use of new agents. Such a framework is within the bounds of present regulatory approaches, is amenable to international harmonisation, and would be a welcome step towards the facilitation of a robust and sustainable discovery and development infrastructure.

• 出版日期2013-3