Traditional FDA approval for Sirturo

The US food and Drug Administration (FDA) has converted Sirturo’s (bedaquiline) accelerated regulatory approval to traditional approval following a determination that a confirmatory trial verified clinical benefit.

Marketed by US health care giant Johnson & Johnson, Sirturo is indicated for pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid, also known as multi-drug resistant tuberculosis (MDR-TB), as part of a combination therapy, for adults and pediatric patients (five years and older, weighing at least 15 kg).

The National TB Surveillance System reported an increase in TB cases in the USA since 2020, including a 16% increase in overall cases in 2023 compared to 2022. MDR-TB typically makes up less than 2% of diagnosed TB cases in the USA.