Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued traditional approval for SIRTURO® (bedaquiline) as part of combination therapy in adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid. With the FDA’s approval, label restrictions that were included when the medicine was granted accelerated approval in the U.S. in December 2012 are removed. The European Commission (EC) has also granted full approval of SIRTURO®, converting its Conditional Marketing Authorisation to a Standard Marketing Authorisation, following a positive opinion in April 2024 from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The approvals were supported by results from the Phase 3 STREAM Stage 2 study (NCT02409290), the first large-scale, randomized, multi-country open-label clinical study to evaluate the efficacy and safety of an all-oral bedaquiline-containing regimen for treatment of MDR-TB. Results confirmed that a bedaquiline-containing regimen offered a significant improvement in treatment outcomes compared to injectable-containing regimens.
SIRTURO® was granted accelerated approval by the FDA in December 2012 and conditional approval by the EMA in March 2014 following positive Phase 2 study data. A supplemental New Drug Application was submitted to the FDA in August 2023 to support the transition to full approval in the U.S. in addition to a Type II variation filed with the European Medicines Agency (EMA) in November 2023 to support the transition to Standard Marketing Authorisation.
Johnson & Johnson’s Commitment to TB Patients
Johnson & Johnson has long been committed to helping end tuberculosis. When Johnson & Johnson introduced SIRTURO®, it was the first medicine for TB with a novel mechanism of action to be introduced in over 40 years. Today, it is a core component of World Health Organization-recommended treatment guidelines for drug-resistant TB, and three of every four MDR-TB patients on treatment are receiving an all-oral regimen containing bedaquiline. More than 845,000 courses of the medicine have been shipped to 160 countries.
Johnson & Johnson has spent the decade since the introduction of SIRTURO® partnering with healthcare providers, communities, governments and non-governmental organizations to help ensure the medicine is accessible and remains effective for patients today and tomorrow. These efforts include investing in critical TB systems capacity, such as healthcare professional training, resistance testing and surveillance, and supply chain security. The Company also supports community-centered initiatives to help identify adults and children living with TB and bring them into treatment, expanding access to TB medicines.
In 2023, Johnson & Johnson granted the Stop TB Partnership’s Global Drug Facility (GDF) a license that enabled GDF to tender, procure and supply generic versions of SIRTURO® for the majority of low-and middle-income countries (LMICs). The Company also confirmed its intent not to enforce bedaquiline patents in 134 low- and middle-income countries.
