In the past 40 years, only two new medications for tuberculosis have been introduced, so agreements to make them available where they are needed most – in the high-burden countries – are critically important.
On 25 February, Otsuka Pharmaceutical announced that it had entered into an agreement with the Stop TB Partnership to make delamanid, its multidrug-resistant TB (MDR-TB) drug, available for procurement through the Global Drug Facility (GDF).
This will be the first time that delamanid (trade name Deltyba™) will be available in low- and middle-income countries. The GDF will make the medicine available as part of second-line therapy for MDR-TB within countries that meet specific criteria: they are eligible for TB financing from the Global Fund, and they follow World Health Organization guidelines for treating MDR-TB within quality-assured programmes. The other new MDR-TB drug, Janssen Pharmaceuticals’ bedaquiline, is also available through the GDF.
“This is very exciting news,” says Dr Paula I Fujiwara, Scientific Director for The Union and an expert on MDR-TB. “Extensive work now lies ahead to introduce these medicines into individual country health systems effectively. An array of stakeholders, including physicians and other health professionals, public health administrators, supply chain managers, quality control agents, drug regulatory authorities, the pharmaceutical manufacturers themselves and others all need to work together to deliver these new medicines to patients who need them.
“TB bacilli are highly susceptible to developing resistance in the face of inadequate or improper TB treatment. This means that all of us must successfully work together to ensure optimal access to delamanid and bedaquiline for patients in need, while safeguarding the efficacy of the medicines by ensuring their proper use within treatment regimens and in a well-run tuberculosis control programme.” The basics cannot be ignored.
According to the WHO, an estimated 480,000 people contracted MDR-TB in 2014 – and most of them never even received a proper diagnosis. Among those diagnosed with MDR-TB, WHO data puts the treatment success rate at only 50 per cent. This is a critical situation, says Fujiwara, which calls for further intensive research into both new TB treatment regimens and new public health solutions.