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FDA approves bedaquiline for TB treatment; first new drug in 40 years

In late December, the US FDA approved bedaquiline for the treatment of MDR-TB on top of the current background regimen. Dr. Chrispin Kambili, an infectious disease specialist at Janssen, recently discussed their research on bedaquiline and reviewed plans for additional research testing on the drug at the 3rd Annual CPTR Workshop this past fall.

Bedaquiline is the first TB drug to be approved in 40 years. This approval by the FDA is an important step in TB drug research and treatment and was highlighted in two recent blog posts by the National Institutes of Health and the Bill & Melinda Gates Foundation.

The FDA approval of bedaquiline is a first step, but much more needs to be done to ensure bedaquiline will have maximal impact on TB. Transformative treatment will come about with the introduction of novel regimens— not single drugs, but entirely new TB drug combinations— that can treat both drug-sensitive and drug-resistant disease.


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