TB Alliance Statement on FDA Approval of Janssen’s Bedaquiline (SIRTURO) for MDR-TB

December 30, 2012

The US FDA approval of bedaquiline is historic, as it marks the first drug in a new class approved to combat TB, and specifically MDR-TB, in more than 40 years. TB Alliance commends Janssen for its substantial work to develop bedaquiline, and FDA for recognizing the urgent need for new MDR-TB drugs and granting bedaquiline’s accelerated approval. We are optimistic that this new drug will help improve treatment for those suffering from MDR-TB.

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. As a partner to Janssen on the comprehensive development of bedaquiline, we are working to develop such transformative treatments.

The global pipeline of new TB drugs is the strongest it has ever been. The FDA approval of bedaquiline brings us closer than ever to the goal shared by Janssen, FDA, and millions of other patients and stakeholders around the world: improving TB treatment for all.