FDA approves bedaquiline as part of therapy for pulmonary tuberculosis

FDA approves bedaquiline as part of therapy for pulmonary tuberculosis | Image Credit: © Calin - © Calin - stock.adobe.com.

The FDA has issued a traditional approval for bedaquiline (SIRTURO; Johnson & Johnson) to be a part of combination therapy for individuals aged 5 years and older with pulmonary tuberculosis (TB) because of Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid.

According to a press release from Johnson & Johnson, label restrictions that were included when the medicine was granted accelerated approval in 2012 are now removed.

The decision was supported by data resulting from the phase 3, STREAM Stage 2 study (NCT02409290), a large-scale, randomized, multi-country, open-label study that evaluated safety and efficacy of an all-oral bedaquiline-containing regimen for treatment of MDR-TB. Results demonstrated that the regimen "offered a significant improvement in treatment outcomes compared to injectable-containing regimens," stated Johnson & Johnson in a press release.

Granted accelerated approval by the FDA in December 2012, a supplemental New Drug Application for bedaquiline was submitted to the FDA in August 2023 to support traditional approval.

According to Johnson & Johnson, bedaquiline should not be used for the treatment of latent infection because of Mycobacterium tuberculosis, drug-sensitive pulmonary or extra-pulmonary TB, or to treat infections caused by non-TB mycobacteria.

Reference:

Johnson & Johnson receives approval from US FDA and European Commission for SIRTURO (bedaquiline). Johnson & Johnson. Press release. July 2, 2024. Accessed July 3, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-approval-from-u-s-fda-and-european-commission-for-sirturo-bedaquiline