U.S. FDA Approves New Pediatric Formulation of SIRTURO ® (bedaquiline) as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis

NEW BRUNSWICK, NJ, May 27, 2020 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new pediatric formulation of SIRTURO® (bedaquiline). SIRTURO® is now indicated for use as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multidrug-resistant tuberculosis (MDR‑TB). In the U.S., the medicine should be reserved for use when an effective treatment regimen cannot otherwise be provided. This indication received accelerated approval based on time to sputum culture conversion. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. SIRTURO® should not be used for the treatment of latent TB infection, extra-pulmonary or drug-sensitive TB, or for the treatment of infections caused by non-tuberculous mycobacteria. The safety and efficacy of SIRTURO® in the treatment of HIV-infected patients with MDR-TB have not been established, as clinical data are limited. Today’s decision marks the first regulatory approval for the pediatric formulation of SIRTURO® and is a key component of Johnson & Johnson’s global pediatric research and development (R&D) program for the medicine. The new 20 mg tablet can be administered with water for patients who are able to swallow the intact tablet and taken with food....
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news