29 March 2010 - South Africa - The US Food and Drug Administration (FDA) is working with public and private sector partners on a new collaboration to significantly accelerate the development of combination treatments for tuberculosis. Created by the Global Alliance for TB Drug Development, the Critical Path Institute and the Bill & Melinda Gates Foundation, the initiative could potentially reduce the time it takes to introduce new combination TB treatments from as much as a quarter century to as few as six years.
Known as the Critical Path to TB Drug Regimens (CPTR), the initiative will test promising combinations of individual TB drug candidates from different companies early in the development pipeline - and identify the best new treatment regimens. Initial groups engaged in CPTR include scientists from FDA and the pharmaceutical companies Johnson & Johnson, sanofi-aventis, Pfizer, AstraZeneca, GlaxoSmithKline, Bayer, Otsuka, Novartis, Sequella and Anacor Pharmaceuticals, Inc. The World Health Organization (WHO) has expressed its support for the initiative.
Currently, obtaining regulatory approval for completely new TB regimens could take 24 years as individual candidates are developed and registered separately and substituted, one at a time, into existing combination therapies. The CPTR initiative has the commitment of the FDA and regulatory authorities in Europe to help develop and validate improved, safe, and accurate regulatory pathways to test and register combination TB treatments.
Nine promising TB compounds from at least six antibiotic classes are currently in clinical trials or late preclinical development, offering an unprecedented opportunity for collaboration. New TB drug combinations could sharply reduce treatment time and prove effective against both drug-susceptible and drug-resistant TB strains. However, given the resilient nature of the TB bacterium and its ability to become resistant to single drugs, TB treatment will still require a combination of antibiotics.
CPTR will be coordinated by the Critical Path Institute - an independent, non-profit organization whose mission is to create innovative collaborations in regulatory science that enable the most efficient and safe medical product development. The collaboration will welcome participation from any company with a promising TB drug candidate in development, as well as other companies and organizations with the technical expertise or resources to help develop new TB regimens.
To facilitate clinical research of combination TB therapies, collaboration partners are also exploring creative funding mechanisms and potential trial site support for Phase IIB and Phase III clinical trials.