Updated on 30 July 2012
The TB Alliance is a product development partnership between public and private organizations dedicated to developing novel TB therapies. Since its inception in 2000, the TB Alliance has developed the world's largest TB drug portfolio and established connections with stakeholders on a global and national scale. The TB Alliance is, therefore, uniquely positioned to develop and distribute novel TB therapies, such as this promising drug cocktail.
An ongoing phase IIb trial to study the drug cocktail in a larger population over a two-month treatment regimen is being conducted in South Africa, Brazil, and Tanzania. If the trial produces similar results to the Phase II trial, developers will likely attempt to fast-track FDA approval via the GAIN Act, which prioritizes antimicrobial therapies for indications with pressing medical need. Earlier this month, Johnson & Johnson submitted an application for accelerated FDA approval for bedaquiline, a compound with activity against drug-resistant TB.
The novel drug cocktail and Otsuka Pharmaceuticals' delamanid could soon join bedaquiline in the race to become the first novel TB therapy in almost half a century.