Patients with multidrug-resistant TB who have additional factors now will have access to the first new type of TB drug approved in more than 40 years, due to a new federal guideline expansion. Sirturo, from Johnson & Johnson (J&J), received approval in 2012 for a narrow group of adults, but on Thursday, CDC approved treatment to include children, pregnant women, and persons with other health complications, such as HIV infection or diabetes.
CDC's guidelines include treatment for categories of patients with drug-resistant strains of TB that have not yet been studied, said Dr. Sundari Mase of CDC's TB elimination branch and lead author of the guidelines. She added that experts have approved most TB drugs to be used for "off label" treatments when "the lack of data did not necessarily mean the drug should not be used in these populations if the risk of not getting appropriate treatment would lead to a really poor outcome—death or (serious illness)."
The lung disease is not common in the United States, but is a global public health threat. The World Health Organization (WHO) reported that approximately 8.6 million people contracted TB in 2012, 1.3 million of whom died from the disease. WHO warned that health systems are overlooking 3 million people with TB, and drug-resistant strains have put progress against TB in danger.
The drug, known generically as bedaquiline, is part of a 24-week drug cocktail regimen. J&J clinical trials showed an increased risk of death, which prompted the US Food and Drug Administration to approve the treatment with the qualification that J&J must collect detailed data on its use, and closely track side effects. "Given that safety concern was there, the group thought if we closely monitor patients and are able to pick up serious adverse events, and side effects are reported and investigated quickly, there should be no reason to limit who gets the drug just based on the increase in all-cause mortality," Mase said.