Johnson & Johnson's SIRTURO® Gains Full Approval in U.S. and Europe: A Milestone in TB Treatment

Beerse, Belgium – Johnson & Johnson proudly announced today that their drug SIRTURO® (bedaquiline) has achieved traditional approval from the U.S. Food and Drug Administration (FDA) and full approval from the European Commission (EC). This significant milestone comes after the drug's initial accelerated approval by the FDA in December 2012 and conditional approval by the European Medicines Agency (EMA) in March 2014.

The approvals are underpinned by robust results from the Phase 3 STREAM Stage 2 study, which demonstrated that an all-oral regimen containing bedaquiline significantly improves treatment outcomes for multi-drug resistant tuberculosis (MDR-TB) compared to injectable-based regimens. These findings, published in The Lancet in November 2022, mark a pivotal advancement in the fight against TB.

FDA and EC Endorsements Reflect Rigorous Clinical Success

With the FDA’s new endorsement, the previous label restrictions imposed during the accelerated approval phase have been lifted. The EC's decision to convert SIRTURO®’s Conditional Marketing Authorisation to a Standard Marketing Authorisation followed a positive opinion from the CHMP in April 2024.

SIRTURO® is now approved for use in combination therapy for both adult and pediatric patients (aged 5 years and older, weighing at least 15 kg) with pulmonary TB resistant to at least rifampicin and isoniazid.

Johnson & Johnson’s Ongoing Commitment to Combating TB

Since its launch, SIRTURO® has been integral to the World Health Organization's guidelines for treating drug-resistant TB. It is currently a key component of treatment regimens for three out of four MDR-TB patients globally, with over 845,000 courses shipped to 160 countries.

Johnson & Johnson continues to collaborate with healthcare providers, communities, and governments to ensure SIRTURO®'s accessibility and effectiveness. This includes investing in healthcare professional training, resistance testing, and supply chain security. The company's efforts also extend to supporting initiatives that identify and treat TB patients, thereby expanding access to essential medicines.

In 2023, Johnson & Johnson granted a license to the Stop TB Partnership’s Global Drug Facility, enabling the procurement and supply of generic versions of SIRTURO® to many low- and middle-income countries. The company also confirmed it would not enforce bedaquiline patents in 134 such countries, reinforcing its dedication to global health.

With these new approvals, Johnson & Johnson remains at the forefront of efforts to end the global TB epidemic, demonstrating a steadfast commitment to innovation and patient care.