Global drugmakers join forces to speed development of new TB drug combinations

Ahead of World TB Day, US Food and Drug Administration Commissioner Margaret Hamburg helped public and private sector partners launch a new collaboration to significantly accelerate the development of combination treatments for tuberculosis - and replace an almost 50-year-old drug regimen. 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 the CPTR include scientists from the FDA and the pharmaceutical companies Johnson & Johnson, Sanofi-Aventis, Pfizer, AstraZeneca, GlaxoSmithKline, Bayer, Otsuka, Novartis, Sequella and Anacor Pharmaceuticals. Also, the World Health Organization (WHO) has expressed its support for the initiative.

"FDA is absolutely committed to working with partners to speed access to new, safe and highly-effective treatments for TB, which continues to mutate and spread," said Dr Hamburg. "I've seen first hand the public health impact and personal tragedy of drug-resistant TB. This creative approach mirrors FDA's own investments in innovative regulatory science that ensures the best new medical technologies - including combination therapies - reach patients as soon as possible," she added.