J&J’s Sirturo for tuberculosis fully approved in US and EU

Johnson & Johnson announced on Tuesday that Sirturo (bedaquiline) has received full approval from both the FDA and the European Commission as part of a combination therapy for treating multidrug-resistant (MDR) pulmonary tuberculosis (TB) in adults and children aged 5 and older, weighing at least 15 kg. Sirturo initially obtained accelerated approval from the FDA for adult usage in 2012. This approval was later expanded to include adolescents in 2019 and children in 2020. Concurrently, the European Medicines Agency (EMA) granted conditional approval in 2014.

Applications to transition to traditional approval were submitted to US and EU regulators in August and November of the previous year. The EU drug advisory panel expressed a positive view in April. The move to full approval was supported by findings from the Phase III STREAM Stage 2 study. This study evaluated an all-oral, Sirturo-based regimen in about 200 patients with MDR-TB, including those with rifampicin-resistant and isoniazid-sensitive infections. The results indicated a notable improvement in treatment outcomes with the Sirturo-based regimen compared to regimens that included injectables.

Johnson & Johnson highlighted that Sirturo was the first TB medicine with a new mechanism of action introduced in over four decades when it launched. The drug has now established itself as a key component in the World Health Organization's recommended treatment guidelines for drug-resistant TB.

Following criticism from advocacy groups over its decision to enforce patents on Sirturo in several countries, Johnson & Johnson announced last year that it would forgo patents in 134 low- and middle-income countries (LMICs). Simultaneously, the company granted the Stop TB Partnership’s Global Drug Facility (GDF) a license to tender, procure, and distribute generic versions of the drug in most LMICs.