Bedaquiline backed by FDA panel

FDA Advisory Committee Recommends Accelerated Approval of JNJ’s Investigational Multi-Drug Resistant Tuberculosis Treatment Bedaquiline


This week while attending the Partnering for Cures meeting in New York (, Bedaquiline was backed by the FDA panel that has been reviewing it since late June. Hopefully, it will be approved by the FDA in due course, because then it becomes the first drug approved for tuberculosis in well over 40 years. This will be a potential success for Johnson and Johnson, the TB Alliance and everyone involved in funding it. While this is terrific news for patients, we need additional molecules in the pipeline, because elevated liver enzymes and QT prolongation were observed. One would assume that it was tested against the ion channel hERG and various nuclear receptors given the size, hydrophobicity, and other physicochemical properties that would alert experts who have studied these proteins and their relationship to QT prolongation and liver enzyme induction?

CDD Public Molecule Bedaquiline

Surprisingly, little mention of this panel decision was made at the meeting in New York, which is unfortunate because the background story behind it illustrates many of the aspects discussed at the meeting. For example Public Private Partnerships (J&J and TB Alliance), PDUFA, Philanthropy etc… Maybe next year it will be highlighted. While not likely to be a very profitable drug it will provide good visibility for J&J and help to bolster the image of a company and an industry that has taken a lot of setbacks in recent years.

Let’s hope it encourages other companies to collaborate to discover drugs for this disease that are faster acting and less toxic than current treatments and that it does not take another 40 years to get there.

Sean Ekins Ph.D, D.Sc.
VP, Science. CDD.

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