Bedaquiline approved by FDA

Sunday, January 06th, 2013 by hinrich

Structure of TMC207/R207910

2012 has ended with great news: TMC207/R207910, the compund we have had in development for the treatment of multi-drug-resistant tuberculosis has been approved by the FDA. Of course, I am biased by having contributed to the science around this compound, so I consider it to be positive news - especially as there have been very few new antibiotics against MTB over the past decades - certainly when looking at novel mechanisms of action.

On the other hand, I am also anxious whether the compound will prove to be sufficiently safe for people to take. The disease is life-threatening, therefore the risk of unwanted effects might be bearable when attempting to safe the life of a patient suffering from MDR-TB. On the other hand, the data from the first trials suggested an increase in the number of deaths due to the addition of TMC207 to the treatment regimen ("Nine patients who received Sirturo died compared with two patients who received placebo."). I hope we will be able to learn quickly what is characteristic for those people dying during the treatment.

Posted in Tuberculosis