Bedaquiline approved as first new TB drug in decades

Bedaquiline is a new drug for tuberculosis (TB) that has made a significant impact in the fight against multidrug-resistant TB. Approved by the U.S. Food and Drug Administration (FDA) in 2012, it is the first new TB drug in 40 years. The journey to its approval was not easy. During early trials, Bedaquiline showed disappointing results. Dr. Koen Andries, the drug’s discoverer, explained that initial tests in mice did not match those in patients. “Our expectations were flawed, not the drug,” he said. Concerns about the drug’s long half-life, which meant it remained in the body for a long time, also raised fears of toxicity. However, studies showed that toxicity only appeared at high doses. Reducing the dose eliminated side effects. The FDA encouraged researchers to extend trials from a week to six months to better understand its effectiveness. By 2012, a major clinical trial confirmed that Bedaquiline worked, leading to its approval just before Christmas that year. Multidrug-resistant TB has become a serious global health issue as TB bacteria evolve to resist standard treatments. Traditional approaches focused on modifying existing drugs, but bacteria quickly adapted. Instead, Bedaquiline was created by blocking ATP synthase, an essential power source for the TB bacteria. This innovative approach was refined by Dr. Jerome Guillemont and led to the development of the effective version of the drug. Despite Bedaquiline’s success, completely eliminating TB remains difficult. About one-third of the world's population has latent TB, meaning they carry the bacteria but show no symptoms. Treating everyone is not feasible, especially since any drug for latent TB must have no side effects. However, Dr. Koen expressed hope in eradicating leprosy, which could potentially follow a successful approach.