Monday, July 15, 2024

Pulmonary Tuberculosis Treatment Gains Full FDA and EC Approval for Johnson & Johnson’s SIRTURO®

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Johnson & Johnson has received traditional approval from the U.S. Food and Dug Administration (FDA) and full approval from the European Commission (EC) for SIRTURO® (bedaquiline) as part of combination therapy for treating pulmonary tuberculosis (TB) in adults and children (5 years and older, weighing at least 15 kg) with drug-resistant TB. The approvals were supported by Phase 3 STREAM Stage 2 study results, confirming significant treatment improvements over injectable-containing regimens.

SIRTURO® was granted accelerated approval by the FDA in December 2012 and conditional approval by the EMA in March 2014. The new approvals remove previous label restrictions and convert the Conditional Marketing Authorisation to Standard Marketing Authorisation in Europe. The decisions followed positive results from a supplemental New Drug Application submitted to the FDA in August 2023 and a Type II variation filed with the EMA in November 2023.

Phase 3 Study Confirms Efficacy of SIRTURO® in Treating Multidrug-Resistant Pulmonary Tuberculosis

The Phase 3 STREAM Stage 2 study (NCT02409290) evaluated the efficacy and safety of an all-oral bedaquiline-containing regimen for treating multidrug-resistant pulmonary tuberculosis (MDR-TB). The study, published in The Lancet in November 2022, confirmed that the bedaquiline-containing regimen significantly improved treatment outcomes compared to injectable-containing regimens.

Johnson & Johnson has long been committed to ending TB. Since introducing SIRTURO®, the first TB medicine with a novel mechanism in over 40 years, the company has worked with healthcare providers, communities, and governments to ensure the medicine’s accessibility and effectiveness. SIRTURO® is now a core component of WHO-recommended treatment guidelines for drug-resistant pulmonary tuberculosis.

Pulmonary Tuberculosis

Johnson & Johnson Expands Global Access to SIRTURO® with Over 845,000 Courses Shipped

More than 845,000 courses of SIRTURO® have been shipped to 160 countries. Johnson & Johnson’s efforts include investing in pulmonary tuberculosis healthcare systems, training professionals, testing resistance, and securing supply chains. The company also supports community initiatives to identify and treat pulmonary tuberculosis patients, expanding access to TB medicines globally.

In 2023, Johnson & Johnson granted the Stop TB Partnership’s Global Drug Facility (GDF) a license to tender, procure, and supply generic versions of SIRTURO® for low- and middle-income countries. Additionally, the company confirmed its intent not to enforce bedaquiline patents in 134 low- and middle-income countries, ensuring broader access to this critical medicine.


Resource: Johnson & Johnson, July 02, 2024

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