First TB drug with a new mechanism of action for 40 years wins approval

Bedaquiline (sirturo) has become the first drug to be approved in the US for the treatment of multi-drug resistant tuberculosis (TB).

The condition arises when Mycobacterium tuberculosis, the bacteria that cause TB, develop resistance to isoniazid and rifampicin, two key drugs for TB treatment. Bedquiline helps by inhibiting an enzyme the bacteria need to replicate and spread through the body.

The drug has been approved through the ‘accelerated approval’ process, which puts drugs on the market earlier than would otherwise be possible while the companies continue to collect clinical trial data. It was developed by Janssen Therapeutics, a subsidiary of US healthcare giant Johnson & Johnson. The company says bedaquiline is the first TB drug with a new mechanism of action for 40 years.

Topics