Bedaquiline regulatory update

The World Health Organization (WHO) issued interim policy guidance recommending the use of Johnson & Johnson's bedaquiline in combination therapy to treat multi-drug resistant tuberculosis (TB). The guidance said 5 conditions should be in place with use of bedaquiline, including close monitoring for effectiveness and safety, informed patient consent and active pharmacovigilance and management of adverse events. Additionally, the guidance noted caution is required when administering bedaquiline to patients >=65 years old and in adults with HIV, and does not recommend administration to children and pregnant women. The guidance also requires treatment to include 4 second-line drugs and recommends bedaquiline alone should not be introduced into a regimen in which the companion drugs are failing to show effectiveness. WHO said it will revise or update the guidance as additional data become available. ...