Ahead of World Tuberculosis (TB) Day, the US Food and Drug Administration (FDA) along with public and private sector partners has launched a new collaboration to accelerate the development of new 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 seeks to reduce the time it takes to introduce new combination TB treatments from as much as 25 years to as little as six.
Known as the Critical Path to TB Drug Regimens, the initiative will test promising combinations of individual TB drug candidates from different companies.
Initial groups engaged in the programme include scientists from the FDA and pharmaceutical companies Johnson & Johnson, Sanofi-Aventis, Pfizer, AstraZeneca, GlaxoSmithKline, Bayer, Otsuka, Novartis, Sequella and Anacor Pharmaceuticals.
FDA Commissioner Margaret Hamburg said that access is needed to new, safe and highly effective treatments for TB, which continues to mutate and spread.
“I’ve seen first hand the public health impact and personal tragedy of drug-resistant TB. Innovative regulatory science must ensure the best new medical technologies – including combination therapies – reach patients as soon as possible,” Hamburg said.
Obtaining regulatory approval for completely new TB regimens can take as long as 24 years as individual candidates are developed and registered separately before being tested as combination therapies.
Global Health Program, Bill & Melinda Gates Foundation president Tadataka Yamada said that a successful drug combination regimen to fight TB could save millions of lives.
“This type of collaboration between the public and the private sector is exactly what’s needed to help speed up the availability of a shorter and more effective treatment for TB,” said Yamada.
TB is one of the world’s deadliest infectious diseases, resulting in the deaths of 1.8 million people each year, mainly in developing countries.