WHO issues interim guidance on new TB drug

The World Health Organization issued interim policy guidance on Thursday related to bedaquiline, a new tuberculosis drug that was recently granted accelerated approval by the U.S. Food and Drug Administration.

In December, the FDA made bedaquiline available, making it the first new TB drug with a novel mechanism of action in more than 40 years. The WHO said that information about the new drug is limited, as it has only been through two Phase IIb trials for efficacy and safety. The agency listed five conditions that must be in place if bedaquiline is to be used to treat adults with multi-drug-resistant-TB.

The WHO said that for bedaquiline to be used, treatment must be closely monitored for safety and effectiveness and special caution should be exercised when the drug is used in people aged 65 and over and adults living with HIV. The drug should not be used in children and pregnant women.

Patients must be made fully aware of the potential benefits and risks of the new drug and must give documented informed consent prior to treatment. Bedaquiline treatment must adhere to all WHO recommendations related to MDR-TB treatment, particularly the inclusion of four effective second-line drugs. Healthcare providers must also put measures into place to make sure that adverse drug reactions and potential interactions with other drugs are detected.

The WHO strongly recommended that Phase III trials be accelerated to generate a more comprehensive base of evidence to guide future bedaquiline policy. The WHO will update the interim guidance when more information on safety and efficacy becomes available.