Janssen's TB drug Sirturo gains US FDA approval

The US Food and Drug Administration has granted accelerated approval for US health care major Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available.

This is the first new medicine to be approved by the FDA to fight the deadly infection in more than four decades. Bedaquiline’s approval under the accelerated system was strongly opposed by US consumer advocacy Public Citizen, which just ahead of the agency’s decision wrote to the FDA saying patients taking the drug in addition to standard TB treatment during a Phase II clinical trial were five times likelier to die than those who took a placebo (The Pharma Letter December 27).

According to the US Centers for Disease Control and Prevention, nearly 9 million people around the world and 10,528 people in the USA became sick with TB in 2011.