Statement on U.S. FDA Approval of Pretomanid as Part of Bedaquiline-Containing “BPaL” Regimen

Johnson & Johnson welcomes the announcement of the accelerated approval by the U.S. Food & Drug Administration (FDA) of pretomanid—a novel medicine developed by the TB Alliance—as part of a combination regimen for the treatment of adults with pulmonary extensively drug-resistant tuberculosis (XDR-TB) or treatment-intolerant or nonresponsive multidrug-resistant (MDR-TB). The regimen—collectively referred to as BPaL—includes Johnson & Johnson’s bedaquiline, along with linezolid. This announcement marks an important milestone in the fight against drug-resistant TB by providing a simpler, shorter treatment option for patients who have historically faced lengthy treatment regimens. The inclusion of bedaquiline in the BPaL regimen underscores the critical role of our medicine in efforts to modernize TB therapy. Johnson & Johnson is committed to providing access to bedaquiline to meet the needs of patients in accordance with World Health Organization (WHO) guidelines for the treatment of drug-resistant tuberculosis, as well as national treatment guidelines. To date, we have delivered more than 125,000 courses of bedaquiline to patients in 127 countries, including the 30 countries designated by WHO as having the highest burden of MDR-TB. Bedaquiline and pretomanid are two of only three new TB therapies to be introduced in the past half a century. Greater innovation will be needed to achieve the global goal of ending the TB pandemic. To this end, Johnson & Johnson is working through its Janssen Pharmaceutical Companies andin partnershipwith external leading academic and research institutions to develop novel TB treatments and combination regimens, as part of our comprehensive10-year initiative on TB. For more information about our TB efforts, please visit:www.jnj.com/tb Discover J&J News Our Credo & our purpose Leadership Social impact Suppliers Our history Policies & reports Environmental sustainability Medicines & therapies Products Oncology Immunology Neuroscience Cardiopulmonary Medical devices & technology Products Cardiovascular Orthopaedics Surgery Vision About us Our company Medicines & therapies Medical devices & technology Careers Investors Media Key links Terms of use Privacy Cookie policy Customize cookie settings Digital Accessibility Statement Get in touch Contact Socials linkedin instagram facebook twitter This website is intended for U.S. audiences only. Do not sell or share my personal information Limit the use of my sensitive personal information © Johnson & Johnson and its affiliates 2026

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