Sirturo Receives Pediatric Indication
August 9, 2019 – The U.S. FDA has approved an expanded indication for Sirturo® (bedaquiline), manufactured by Janssen Pharmaceuticals. The product is now approved for use as part of combination therapy to treat pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult and pediatric patients at least 12 years of age who weigh no less than 30kg (66 pounds). Sirturo should be used only when an effective treatment regimen cannot otherwise be provided.
Tuberculosis, one of the world’s deadliest diseases, is known for developing resistance to antibiotics. Patients with MDR-TB may have limited treatment options. Successful treatment may require a number of medications taken over the course of months to years. The disease is caused by Mycobacterium tuberculosis, and can be spread through the air every time an infected individual coughs, sneezes, laughs, speaks, or sings. Although most TB infections attack the lungs (pulmonary), they can affect any part of the body, including the brain, spine, and kidneys.
In a clinical study, six out of eight pediatric patients with culture-positive pulmonary MDR-TB achieved a negative culture by week 24. Recommended dosing is the same for children as in adults—400mg once daily for two weeks, followed by 200mg three times per week for the 22 weeks. Sirturo must be used in combination with at least three other drugs to which the patient’s MDR-TB isolate has been shown to be susceptible in vitro. If in vitro testing results are unavailable, healthcare providers may initiate Sirturo in combination with at least four other drugs to which patient’s MDR-TB isolate is likely to be susceptible.
A black box warning cautions that in clinical studies, there was an increased risk of mortality amongst adult patients treated with Sirturo compared to placebo. The black box warning also advises that there is a risk of QT prolongation, a heart rhythm disorder.
Because the FDA granted an accelerated approval for Sirturo’s expanded indication, continued approval for the indication may be contingent upon verification of clinical benefit in confirmatory trials. Janssen is also investigating the use of Sirturo in patients less than 12 years of age.