FDA Is Easing Way for Drug Cocktails

The Food and Drug Administration (FDA) is drafting guidelines for a new approval process governing multidrug therapies for life-threatening diseases. The regulations would pertain to diseases for which good treatments do not exist, as well to those for which drug combinations are believed to be necessary. New TB treatments could get a boost from the revised rules.

FDA traditionally has required each new drug to be tested and approved individually. Combination regimes would have to build from that initial work. Under the new system, FDA could for the first time approve drug cocktails whose individual components are all new. The draft rules could be published by this summer. FDA would then solicit public feedback and finalize the guidelines.

A regimen of wholly new TB drugs could help cure even patients whose strain is resistant to every current therapy, experts say. About a third of TB patients globally are infected with strains resistant to at least one first-line treatment. Multidrug-resistant TB strains take two years to treat, have a lower cure rate, and the drugs can cause severe side effects.

At least nine experimental TB drugs are in early-stage human trials, potentially opening a historic opportunity to mix and match the agents and create the best regimens, said Peter Small, head of the Bill and Melinda Gates Foundation's TB efforts.

The foundation's "Critical Path to TB Regimens" collaboration, a group of 10 drug companies and several nonprofit organizations convened to develop TB drugs, could benefit from the new system. CPTR partners are set to agree to data sharing and testing new combination treatments early in the drug development process.

Helping launch CPTR were the nonprofit Global Alliance for TB Drug Development and the Critical Path Institute, an FDA-University of Arizona partnership to develop new methods of evaluating drugs. In the past year, FDA Commissioner Dr. Margaret Hamburg has twice met with the foundation, which has asked for her commitment to testing multidrug TB treatments.


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