Both studies were designed to measure how long it takes patients to be free of tuberculosis. The FDA said it approved the drug based on two mid-stage studies enrolling 440 patients taking Sirturo.
“But the FDA had not yet answered concerns related to unexplained increases in toxicity and death in patients getting the drug.” “The fact that bedaquiline is part of a new class of drug means that an increased level of scrutiny should be required for its approval,” the group states. Last week, the consumer advocacy group Public Citizen criticized that approach, noting the drug’s outstanding safety issues. The fact that bedaquiline is part of a new class of drug means that an increased level of scrutiny should be required for its approval Five of the deaths in the Sirturo group seemed to be related to tuberculosis, but no explanation was apparent for the remaining four.ĭespite the deaths, the FDA approved the drug under its accelerated approval program, which allows the agency to clear innovative drugs based on promising preliminary results. Nine patients taking Sirturo died in company testing compared with two patients taking a placebo. “However, because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don’t have other treatment options.”
“Sirturo provides much-needed treatment for patients who have don’t have other therapeutic options available,” said Edward Cox, director of the FDA’s antibacterial drugs office. The drug carries a boxed warning indicating that it can interfere with the heart’s electrical activity, potentially leading to fatal heart rhythms. Sirturo provides much-needed treatment for patients who have don’t have other therapeutic options available “The antibiotics used to treat it have been around for at least 40 years and so the bacterium has become more and more resistant to what we have,” said Chrispin Kambili, global medical affairs leader for J&J’s Janssen division. The standard drugs used to fight the disease were developed in the 1950s and 1960s. This advertisement has not loaded yet, but your article continues below. Manage Print Subscription / Tax Receipt.