7 January 2013 - Geneva - On 29-30 January the World Health Organization (WHO) will convene an expert group meeting on the use of bedaquiline for treatment of multidrug-resistant tuberculosis (MDR-TB).
The meeting follows the approval of the new TB drug on 28 December by the United States Food and Drug Administration (FDA) as part of combination therapy to treat adults in the US with MDR-TB when other alternatives are not available.
Experts at the WHO meeting will review the available evidence on the safety and effectiveness of bedaquiline, provide advice on its potential contribution to MDR-TB treatment and recommend whether WHO should produce provisional guidance on the use of the drug to supplement its existing guidance on the MDR-TB treatment.
Bedaquiline is the first new anti-TB drug to be approved by the FDA in more than 40 years. It was approved under the FDA’s accelerated review program that allows promising drugs to be brought to market more quickly. Developed by Janssen Therapeutics, a division of US company Johnson & Johnson, bedaquiline is marketed using the trade name Sirturo. The drug works by blocking an enzyme that the TB bacterium needs to replicate and spread through the body.
TB groups have applauded the FDA’s decision "The 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. We are optimistic that this new drug will help improve treatment for those suffering from MDR-TB," the TB Alliance said in a statement.
Mark Harrington, Executive Director of Treatment Action Group (TAG), said that the FDA has sent a clear signal that there is hope for people with MDR-TB and that fighting TB is a priority. "Over one million people need new TB drugs this year, and the FDA’s approval shows that there is a clear regulatory pathway for approving new TB treatments and regimens," he said.
While welcoming this development, TAG and other groups have joined WHO in urging caution regarding the drug’s use and called for phase III trials to produce further efficacy and safety data. Currently available data on bedaquiline comes from phase IIb trials that included 440 participants. WHO also advises that a single drug deemed to be effective - such as bedaquiline - should never be added alone to a regimen to which a patient is not responding.
"It’s exciting to have the first new TB drug in so many years, and I look forward to the outcomes of the WHO experts meeting," said Dr Lucica Ditiu, Executive Secretary of the Stop TB Partnership. "This new drug has potential but we need to use it wisely in carefully selected candidates to maintain its efficacy."
MDR-TB occurs when the mycobacterium becomes resistant to isoniazid and rifampicin, the two most effective anti-TB drugs commonly used to treat TB. MDR-TB can occur when people can’t or don’t complete their treatment. It can also be transmitted from one person to another. Nearly half a million people got MDR-TB in 2011.