New TB drug bedaquiline illustrates need for paradigm shift in developing and ensuring access to new treatment combinations.

Paris, October 30, 2013: Without a new approach to developing and pricing new tuberculosis medicines, the global TB response will be unable to deliver the new treatment combinations needed to close the deadly treatment gap for drug-resistant tuberculosis (DR-TB), warned the international medical humanitarian group Doctors Without Borders/Médecins Sans Frontières (MSF) at the Union World Conference on Lung Health in Paris.

“If I could change anything about having TB it would be the treatment; if we could have less toxic drugs and simpler, shorter treatment regimens, there would be fewer people dropping out of treatment and fewer people dying”, said Phumeza Tisile, who received TB treatment through MSF’s programme in Khayelitsha, South Africa.

In December 2012, a 50 year drought in TB drug research and development (R&D) came to an end with the approval in the U.S. of bedaquiline, a novel TB medicine marketed by Janssen, a subsidiary of Johnson & Johnson (J&J).

“This is a significant milestone for clinicians and patients, but there is no room for complacency or celebration yet. The new drug is obviously a boon, but what we really need are entire new combinations of drugs to treat DR-TB,” said Dr Cathy Hewison, TB advisor for MSF. “If we are unable to offer patients an entirely new, tolerable and more effective regimen in the coming years, the opportunity to radically improve DR-TB treatment will be squandered.”

The U.S. Food and Drug Administration fast-tracked the approval of bedaquiline, the World Health Organization (WHO) issued rapid guidelines for its use, and J&J has pushed for registration fairly widely; these are positive signals that the TB context is ready to respond quickly to new drugs.  But achieving the goal of entirely new regimens requires a more fundamental change in the way TB drugs are researched and brought to market.

Related: Test Me, Treat Me: A Drug-Resistant TB manifesto