TAC puts pressure on Janssen finalize development of TB drug bedaquiline

The current standard of care for multi-drug resistant tuberculosis (MDR-TB) consists of poorly tested drugs with horrible side-effects, and there is a desperate need to put pressure on governments and the pharmaceutical industry to increase investment in better TB diagnostics and newer, better TB drugs, says the South Africa-based Treatment Action Group (TAC) in a web site posting.

Bedaquiline, made by Janssen, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), is a promising drug for treating drug-resistant TB. Two phase II trials have shown compelling evidence that the drug is effective at destroying TB bacteria in the body, however there are safety concerns. In one trial more deaths occurred in the bedaquiline arm than the control.

In December 2012 the US Food and Drug Administration gave accelerated approval to bedaquiline (under the trade name Sirturo) on condition that a Phase III trial be conducted and reported on by 2022. “We welcome the requirement for a Phase III trial. However, the 2022 deadline is far too late and shows little awareness for the urgency to test new TB drugs and determine their safety. Also, very few people in the USA will need bedaquiline. TB is not an epidemic in the USA,” said the TAC.

Around the time of the US approval, analysts at Cowen and Co forecast peak annual sales of $300 million for bedaquiline, noting that this would make it a fairly modest product for the company (The Pharma Letter November 29, 2012).

No urgency shown in conducting the Ph III study

Following the FDA approval, Janssen has shown no urgency to conduct a Phase III trial. This could be because of the lack of profit Janssen expects from TB drugs as well as the possibility of a Phase III trial confirming safety concerns. Activists across the world have to put pressure on Janssen to begin a phase III trial urgently.

The TAC said it recently contacted South Africa’s Medicines Control Council (MCC) to inquire about the status of Janssen’s application to register Bedaquiline in South Africa. It was told that the MCC’s review of the application is ongoing. Given the lack of data from a Phase III trial and the worrying safety data, a decision by the MCC to reject the application would not be unreasonable. The TAC supports bedaquiline being offered to patients with drug-resistant TB under compassionate use (as is currently done in South Africa), so long as patients are properly informed of the drug's risks and benefits.