This afternoon, FDA Commissioner is expected to help launch the Critical Path to TB Drug Regimens (CPTR)—an initiative aimed at accelerating the development and approval of new treatments for tuberculosis (TB). Supporting the initiative are the TB Alliance, the Bill & Melinda Gates Foundation, the Critical Path Institute (C-Path), and 10 pharmaceutical companies: Johnson & Johnson, sanofi-aventis, Pfizer, AstraZeneca, GlaxoSmithKline, Bayer, Otsuka, Novartis, Sequella and Anacor Pharmaceuticals.

The groundbreaking initiative will focus on nine potential drug compounds with potential for treating TB. The compounds—which come from the sponsoring companies—are already in the pipeline in early-clinical stages. “The current first-line TB drug regimen of four drugs is more than 40 years old, takes six to nine months to complete and has significant side effects,” according to a release from the TB Alliance. But in recent years, TB has been shown to respond better to a combination of drug therapies. By testing these nine candidates (and potentially others as well) together, a combination treatment may be available in as few as six years instead of 24, which is the time it could take to develop and get approval for each of the drugs separately, according to the TB Alliance.

As early as 10 years ago, there were no TB drug candidates under development. “Now, however, we have multiple new drugs in clinical development which makes pursuing the CPTR initiative practical and feasible,” Mel Spigelman, MD, president and CEO of the TB Alliance, told Pharmaceutical Technology. “There is also much greater industry commitment to new TB drug than there has been in decades.”

Under CPTR, drug companies and other product developers will test promising combinations of individual TB drug candidates to identify the best new combinations. Participants will also work closely with FDA and other regulators to develop new tools and pathways to evaluate and register the potential new therapies in quick manner, according to the TB Alliance.

The groundbreaking initiative will be coordinated by the TB Alliance. All sponsors of the individual compounds included in the initiative will have a say in decisions made regarding the project. “CPTR trials will be designed to facilitate the most efficient and expedient path to TB regimen development. It is not just in the best interest of the millions suffering from TB that a wide array of organizations participate in the initiative, but also in the financial and practical interest of the organizations themselves,” says Spigelman.

Although the global market for first-line TB drugs is only slightly more than $300 million, according to TB Alliance research, the program is critical to global health and the 1.8 million people who die from TB each year.

With the new initiative, the launch of the first clinical trial in humans could begin as early as the end of this year. And if successful, there is opportunity for the CPTR model to be applied to other diseases in which combination treatment is necessary such as cancer and hepatitis.